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Prevention of GBS Colonization Via Immunity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128219
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : July 5, 2010
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Beta Haemolytic Streptococcal Infection
Interventions Biological: GBS III-TT
Biological: Tetanus and diptheria toxoids vaccine
Enrollment 667
Recruitment Details 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
Pre-assignment Details Participants were screened for vaginal and rectal colonization with type III GBS and only those negative were offered enrollment
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description 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). The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Period Title: Overall Study
Started 333 334
Completed 264 263
Not Completed 69 71
Arm/Group Title GBS III-TT Vaccine Td Vaccine Total
Hide Arm/Group Description 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). The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). Total of all reporting groups
Overall Number of Baseline Participants 333 334 667
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants 334 participants 667 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
333
 100.0%
334
 100.0%
667
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 333 participants 334 participants 667 participants
26.2  (5.58) 26.1  (5.68) 26.2  (5.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 333 participants 334 participants 667 participants
Female
333
 100.0%
334
 100.0%
667
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 333 participants 334 participants 667 participants
333 334 667
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Measure Type: Number
Unit of Measure: Participants
Month 0 to 2 at risk 325 325
Month 0 to 2 with GBS 20 15
Month 0 to 2 censored 18 15
Month 2 to 4 at risk 287 295
Month 2 to 4 with GBS 5 6
Month 2 to 4 censored 13 7
Month 4 to 6 at risk 269 282
Month 4 to 6 with GBS 1 7
Month 4 to 6 censored 8 7
Month 6 to 8 at risk 260 268
Month 6 to 8 with GBS 3 8
Month 6 to 8 censored 10 9
Month 8 to 10 at risk 247 251
Month 8 to 10 with GBS 0 2
Month 8 to 10 censored 8 6
Month 10 to 12 at risk 239 243
Month 10 to 12 with GBS 0 7
Month 10 to 12 censored 4 12
Month 12 to 14 at risk 235 224
Month 12 to 14 with GBS 2 3
Month 12 to 14 censored 7 3
Month 14 to 16 at risk 226 218
Month 14 to 16 with GBS 2 3
Month 14 to 16 censored 4 3
Month 16 to 18 at risk 220 212
Month 16 to 18 with GBS 1 2
Month 16 to 18 censored 185 168
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GBS III-TT Vaccine, Td Vaccine
Comments Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments The a priori threshold for statistical significance was set at 0.05.
Method Regression, Cox
Comments The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.
Method of Estimation Estimation Parameter Vaccine Efficacy, VE=1-RR=1-exp(ß)
Estimated Value 36
Confidence Interval (2-Sided) 95%
1 to 58
Estimation Comments Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.
2.Secondary Outcome
Title Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination.
Hide Description 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.
Time Frame Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/ml
Month 0
0.29
(0.25 to 0.35)
0.31
(0.26 to 0.37)
Month 1
12.35
(9.60 to 15.90)
0.29
(0.24 to 0.35)
Month 2
12.55
(9.95 to 15.81)
0.30
(0.25 to 0.35)
Month 4
9.58
(7.67 to 11.97)
0.29
(0.24 to 0.34)
Month 6
7.26
(5.84 to 9.03)
0.29
(0.24 to 0.34)
Month 8
6.63
(5.32 to 8.27)
0.26
(0.22 to 0.32)
Month 10
5.80
(4.64 to 7.24)
0.28
(0.23 to 0.33)
Month 12
5.16
(4.14 to 6.43)
0.27
(0.22 to 0.32)
Month 14
4.80
(3.84 to 6.00)
0.26
(0.22 to 0.32)
Month 16
4.57
(3.67 to 5.69)
0.28
(0.23 to 0.34)
Month 18
3.99
(3.22 to 4.94)
0.27
(0.22 to 0.33)
3.Secondary Outcome
Title Number of Participants With Any Solicited Local and Systemic Symptoms.
Hide Description 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.
Time Frame Safety surveillance during the 1st 7 days.
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 326 337
Measure Type: Number
Unit of Measure: Participants
General Arm Pain 175 223
Local Redness 27 40
Local Swelling 23 52
Local Tenderness at Injection Site 234 276
Any Solicited Local Symptom 251 294
Chills 30 33
Headache 130 118
Elevated Oral Temperature (>37.4 degrees Celsius) 33 32
Malaise (Decreased energy) 103 111
Myalgia (General muscle aches) 91 112
Nausea 55 61
Any Solicited Systemic Symptom 208 206
Any Solicited Symptom 282 307
4.Secondary Outcome
Title Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination
Hide Description 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.
Time Frame Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Mean (95% Confidence Interval)
Unit of Measure: Ratio
Month 0
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Month 1
41.29
(34.70 to 49.12)
0.99
(0.95 to 1.03)
Month 2
41.06
(35.27 to 47.80)
0.98
(0.94 to 1.02)
Month 4
31.64
(27.35 to 36.60)
0.93
(0.90 to 0.97)
Month 6
25.56
(22.07 to 29.59)
0.92
(0.88 to 0.97)
Month 8
21.92
(18.95 to 25.36)
0.89
(0.84 to 0.94)
Month 10
19.78
(17.08 to 22.91)
0.91
(0.87 to 0.96)
Month 12
17.71
(15.30 to 20.50)
0.91
(0.86 to 0.96)
Month 14
16.76
(14.41 to 19.49)
0.92
(0.87 to 0.98)
Month 16
15.89
(13.70 to 18.42)
0.90
(0.85 to 0.95)
Month 18
14.26
(12.33 to 16.48)
0.92
(0.87 to 0.97)
5.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 1 month following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 304 303
Measure Type: Number
Unit of Measure: participants
277 1
6.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 2 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 301 310
Measure Type: Number
Unit of Measure: participants
286 1
7.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 4 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 289 298
Measure Type: Number
Unit of Measure: participants
272 2
8.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 6 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 279 287
Measure Type: Number
Unit of Measure: participants
264 1
9.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 8 month following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 275 278
Measure Type: Number
Unit of Measure: participants
256 1
10.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 10 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 271 262
Measure Type: Number
Unit of Measure: participants
250 1
11.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 12 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 271 274
Measure Type: Number
Unit of Measure: participants
245 2
12.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 14 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 258 261
Measure Type: Number
Unit of Measure: participants
231 3
13.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 16 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 256 260
Measure Type: Number
Unit of Measure: participants
228 2
14.Secondary Outcome
Title Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination
Hide Description 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.
Time Frame Prior to and 18 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 264 261
Measure Type: Number
Unit of Measure: participants
229 1
15.Secondary Outcome
Title Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0
Hide Description 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.
Time Frame Month 0 prior to vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Measure Type: Number
Unit of Measure: participants
25 18
16.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 304 303
Measure Type: Number
Unit of Measure: participants
192 12
17.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 301 310
Measure Type: Number
Unit of Measure: participants
186 13
18.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 289 298
Measure Type: Number
Unit of Measure: participants
174 12
19.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 279 287
Measure Type: Number
Unit of Measure: participants
155 11
20.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 275 278
Measure Type: Number
Unit of Measure: participants
151 9
21.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 271 262
Measure Type: Number
Unit of Measure: participants
137 10
22.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 271 274
Measure Type: Number
Unit of Measure: participants
136 10
23.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 258 261
Measure Type: Number
Unit of Measure: participants
126 9
24.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 256 260
Measure Type: Number
Unit of Measure: participants
122 8
25.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 264 261
Measure Type: Number
Unit of Measure: participants
117 9
26.Secondary Outcome
Title Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study.
Hide Description 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.
Time Frame Every 2 months from time of vaccination up to 18 months post-vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Measure Type: Number
Unit of Measure: Participants
Always Vaginal Negative – False 39 54
Always Vaginal Negative – True 286 271
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GBS III-TT Vaccine, Td Vaccine
Comments A two-sided 5% level Fisher’s exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher’s exact test was inverted to obtain a 95% confidence interval for the odds ratio.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.
Method Fisher Exact
Comments Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.460
Confidence Interval (2-Sided) 95%
0.917 to 2.34
Estimation Comments The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher’s exact, with GBS III-TT arm in the numerator and Td arm in the denominator so <1 favors the GBS III-TT arm.
27.Secondary Outcome
Title Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive.
Hide Description 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.
Time Frame Every 2 months from time of vaccination up to 18 months post-vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Measure Type: Number
Unit of Measure: Participants
Month 1 - Missing 5 2
Month 1 - Negative 313 314
Month 1 - Positive 7 9
Month 2 - Missing 8 7
Month 2 - Negative 303 310
Month 2 - Positive 14 8
Month 4 - Missing 24 15
Month 4 - Negative 292 301
Month 4 - Positive 9 9
Month 6 - Missing 25 22
Month 6 - Negative 293 291
Month 6 - Positive 7 12
Month 8 - Missing 34 29
Month 8 - Negative 282 279
Month 8 - Positive 9 17
Month 10 - Missing 41 38
Month 10 - Negative 279 273
Month 10 - Positive 5 14
Month 12 - Missing 48 42
Month 12 - Negative 272 266
Month 12 - Positive 5 17
Month 14 - Missing 52 51
Month 14 - Negative 268 259
Month 14 - Positive 5 15
Month 16 - Missing 58 56
Month 16 - Negative 260 257
Month 16 - Positive 7 12
Month 18 - Missing 61 62
Month 18 - Negative 256 255
Month 18 - Positive 7 8
All Clinic Visits - Missing 356 324
All Clinic Visits - Negative 3138 3126
All Clinic Visits – Positive 80 125
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GBS III-TT Vaccine, Td Vaccine
Comments The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.
Method Binomial regression, log-linear link
Comments The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.
Method of Estimation Estimation Parameter Vaccine Efficacy, VE=1-RR=1-exp(ß)
Estimated Value 36
Confidence Interval 95%
-7 to 61
Estimation Comments Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.
28.Secondary Outcome
Title Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits
Hide Description 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.
Time Frame Every 2 months from time of vaccination up to 18 months post-vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Measure Type: Number
Unit of Measure: Participants
Persistent Colonization – False 318 312
Persistent Colonization - True 7 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GBS III-TT Vaccine, Td Vaccine
Comments A two-sided 5% level Fisher’s exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher’s exact test was inverted to obtain a 95% confidence interval for the odds ratio.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.
Method Fisher Exact
Comments Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.18 to 1.45
Estimation Comments The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher’s exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value <1 favors the GBS III-TT arm.
29.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 0
Hide Description 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.
Time Frame Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 325 325
Measure Type: Number
Unit of Measure: Swabs
Negative 321 320
Broth only 0 1
1+ 0 0
2+ 0 0
3+ 0 0
4+ 4 4
30.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 1
Hide Description 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.
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 323 320
Measure Type: Number
Unit of Measure: Swabs
Negative 314 313
Broth only 1 1
1+ 0 1
2+ 1 1
3+ 2 3
4+ 5 1
31.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 2
Hide Description 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.
Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 318 317
Measure Type: Number
Unit of Measure: Swabs
Negative 310 303
Broth only 0 1
1+ 0 1
2+ 2 1
3+ 1 2
4+ 5 9
32.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 4
Hide Description 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.
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 310 301
Measure Type: Number
Unit of Measure: Swabs
Negative 301 292
Broth only 2 0
1+ 1 2
2+ 2 0
3+ 1 3
4+ 3 4
33.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 6
Hide Description 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.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 303 300
Measure Type: Number
Unit of Measure: Swabs
Negative 291 293
Broth only 1 2
1+ 0 0
2+ 1 0
3+ 2 2
4+ 8 3
34.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 8
Hide Description 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.
Time Frame Month 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 296 291
Measure Type: Number
Unit of Measure: Swabs
Negative 279 282
Broth only 3 1
1+ 0 0
2+ 0 2
3+ 1 2
4+ 13 4
35.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 10
Hide Description 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.
Time Frame Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 287 284
Measure Type: Number
Unit of Measure: Swabs
Negative 273 279
Broth only 2 1
1+ 0 0
2+ 3 1
3+ 3 0
4+ 6 3
36.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 12
Hide Description 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.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 283 277
Measure Type: Number
Unit of Measure: Swabs
Negative 266 272
Broth only 2 0
1+ 0 0
2+ 3 1
3+ 1 2
4+ 11 2
37.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 14
Hide Description 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.
Time Frame Month 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 274 273
Measure Type: Number
Unit of Measure: Swabs
Negative 259 268
Broth only 3 0
1+ 2 1
2+ 1 0
3+ 4 2
4+ 5 2
38.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 16
Hide Description 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.
Time Frame Month 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 269 267
Measure Type: Number
Unit of Measure: Swabs
Negative 257 260
Broth only 2 2
1+ 1 1
2+ 1 0
3+ 3 0
4+ 5 4
39.Secondary Outcome
Title The Density of Type III GBS Cultured From Vaginal Swabs at Month 18
Hide Description 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.
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description:
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).
The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
Overall Number of Participants Analyzed 263 263
Measure Type: Number
Unit of Measure: Swabs
Negative 255 256
Broth only 0 2
1+ 1 0
2+ 1 1
3+ 2 0
4+ 4 4
Time Frame 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.
Adverse Event Reporting Description 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).
 
Arm/Group Title GBS III-TT Vaccine Td Vaccine
Hide Arm/Group Description 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. 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.
All-Cause Mortality
GBS III-TT Vaccine Td Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
GBS III-TT Vaccine Td Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/326 (4.29%)      22/337 (6.53%)    
Cardiac disorders     
Cardiac failure congestive * 1  1/326 (0.31%)  1 0/337 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal inflammation * 1  1/326 (0.31%)  1 0/337 (0.00%)  0
Pancreatitis * 2  0/326 (0.00%)  0 1/337 (0.30%)  1
General disorders     
Chest pain * 3  0/326 (0.00%)  0 1/337 (0.30%)  1
Death * 4  1/326 (0.31%)  1 0/337 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis * 1  1/326 (0.31%)  1 1/337 (0.30%)  1
Gallbladder pain * 4  0/326 (0.00%)  0 1/337 (0.30%)  1
Infections and infestations     
Appendicitis * 5  0/326 (0.00%)  0 2/337 (0.59%)  2
Cellulitis * 5  1/326 (0.31%)  1 0/337 (0.00%)  0
Pyelonephritis * 3  1/326 (0.31%)  1 1/337 (0.30%)  1
Staphylococcal infection * 6  0/326 (0.00%)  0 1/337 (0.30%)  1
Subcutaneous abscess * 5  0/326 (0.00%)  0 1/337 (0.30%)  1
Tooth abscess * 4  0/326 (0.00%)  0 1/337 (0.30%)  1
Urinary tract infection * 6  0/326 (0.00%)  0 1/337 (0.30%)  1
Injury, poisoning and procedural complications     
Head injury * 3  0/326 (0.00%)  0 1/337 (0.30%)  1
Polytraumatism * 6  1/326 (0.31%)  1 0/337 (0.00%)  0
Post procedural haemorrhage * 3  1/326 (0.31%)  1 0/337 (0.00%)  0
Thermal burn * 4  1/326 (0.31%)  1 0/337 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoporosis * 1  1/326 (0.31%)  1 0/337 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma * 1  0/326 (0.00%)  0 1/337 (0.30%)  1
Nervous system disorders     
Convulsion * 7  1/326 (0.31%)  1 0/337 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy * 8  0/326 (0.00%)  0 2/337 (0.59%)  2
Pre-eclampsia * 7  0/326 (0.00%)  0 1/337 (0.30%)  1
Premature labour * 3  0/326 (0.00%)  0 1/337 (0.30%)  1
Premature rupture of membranes * 5  0/326 (0.00%)  0 1/337 (0.30%)  1
Psychiatric disorders     
Affective disorder * 1  1/326 (0.31%)  1 0/337 (0.00%)  0
Bipolar disorder * 5  0/326 (0.00%)  0 1/337 (0.30%)  1
Mental disorder * 5  1/326 (0.31%)  1 0/337 (0.00%)  0
Psychotic disorder * 1  1/326 (0.31%)  1 0/337 (0.00%)  0
Nephrolithiasis * 4  0/326 (0.00%)  0 1/337 (0.30%)  1
Respiratory, thoracic and mediastinal disorders     
Throat lesion * 1  0/326 (0.00%)  0 1/337 (0.30%)  1
Surgical and medical procedures     
Gastric bypass * 3  1/326 (0.31%)  1 1/337 (0.30%)  1
Hysterectomy * 4  0/326 (0.00%)  0 1/337 (0.30%)  1
Vascular disorders     
Deep vein thrombosis * 5  0/326 (0.00%)  0 1/337 (0.30%)  1
*
Indicates events were collected by non-systematic assessment
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Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GBS III-TT Vaccine Td Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   304/326 (93.25%)      320/337 (94.96%)    
Gastrointestinal disorders     
Nausea  6  54/326 (16.56%)  54 61/337 (18.10%)  61
General disorders     
Tenderness  5  234/326 (71.78%)  234 276/337 (81.90%)  276
Pain (at Injection Site)  6  175/326 (53.68%)  175 223/337 (66.17%)  223
Malaise  5  103/326 (31.60%)  103 111/337 (32.94%)  111
Injection site swelling  5  32/326 (9.82%)  32 54/337 (16.02%)  54
Injection site erythema  5  39/326 (11.96%)  39 45/337 (13.35%)  45
Pyrexia  6  33/326 (10.12%)  33 32/337 (9.50%)  32
Chills  9  30/326 (9.20%)  30 33/337 (9.79%)  33
Infections and infestations     
Nasopharyngitis * 1  56/326 (17.18%)  61 55/337 (16.32%)  71
Vaginitis bacterial * 2  44/326 (13.50%)  51 61/337 (18.10%)  90
Fungal infection * 3  44/326 (13.50%)  52 45/337 (13.35%)  68
Urinary tract infection * 3  35/326 (10.74%)  46 29/337 (8.61%)  34
Sinusitis * 4  23/326 (7.06%)  33 30/337 (8.90%)  38
Vulvovaginal mycotic infection * 4  18/326 (5.52%)  19 19/337 (5.64%)  26
Influenza * 4  14/326 (4.29%)  15 19/337 (5.64%)  21
Musculoskeletal and connective tissue disorders     
Myalgia  8  91/326 (27.91%)  91 112/337 (33.23%)  112
Nervous system disorders     
Headache * 2  35/326 (10.74%)  37 44/337 (13.06%)  52
Headache  7  130/326 (39.88%)  130 119/337 (35.31%)  119
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V9.1
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Term from vocabulary, MedDRA V10.0
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Term from vocabulary, MedDRA V10.1
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Term from vocabulary, MedDRA V9.0
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Term from vocabulary, MedDRA 8.0
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Term from vocabulary, MedDRA 9.0
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Term from vocabulary, MedDRA 10.0
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Term from vocabulary, MedDRA 11.0
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Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Sharon Hillier, Ph.D.
Organization: University of Pittsburgh School of Medicine
Phone: 412-641-6435
EMail: hillsl@mwri.magee.edu
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00128219    
Other Study ID Numbers: 02-015
First Submitted: August 5, 2005
First Posted: August 9, 2005
Results First Submitted: August 3, 2009
Results First Posted: July 5, 2010
Last Update Posted: January 27, 2015