Beta Haemolytic Streptococcal Infection
Conditions
Keywords
Group B Streptococcus, women, vaccine
Brief summary
The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina. Approximately 600 women, ages 18-40, will be enrolled from the clinical sites participating in this study. Participants will be non-pregnant, sexually active (sex with a male at least once in the last 4 months), and GBS negative in the vagina or rectum at the screening visit. Participants will be randomly assigned to receive the experimental GBS type III vaccine or a licensed vaccine containing Tetanus and Diphtheria Toxoids (Td). Participants will be followed at one month, 2 months and every other month thereafter following vaccination (for vaginal and rectal swab collection and a blood draw) for 1½ years or a total of 10 post vaccination visits.
Detailed description
Vaginal colonization is the single most important risk factor for transmission of group B Streptococcus (GBS) from mothers to neonates, resulting in neonatal sepsis and/or meningitis. The long-term goal of this study is to determine whether vaccine-induced serum antibody to type III GBS will be sufficient to prevent vaginal acquisition of type III GBS. This study is linked to Division of Microbiology and Infectious Diseases protocol 04-018. It is a randomized, double-blinded, comparative clinical trial among young (18-40 years old), non-pregnant, sexually active women who are not currently colonized vaginally or rectally with type III GBS, it will be conducted to evaluate the efficacy of a GBS type III-TT vaccine for prevention of type III GBS vaginal acquisition. The observation period for each patient will be 18 months following vaccination. The specific objectives are: enroll 600 women (previously screened within last 14 days in a GBS Screening Protocol) identified as GBS type III negative, vaginally and rectally; vaccinate 600 women randomized to a 1:1 ratio with 50 micrograms of type III GBS polysaccharide conjugated to tetanus toxoid (GBS III-TT) or licensed vaccine containing Tetanus and Diphtheria Toxoids adsorbed for adult use (Td); measure reactogenicity by subject report in a 7-day symptom diary and by 1-2 day follow-up telephone call; evaluate women at 1, 2, 4, 6, 8, 10, 12, 14, 16 and 18 months for serum antibody response. Blood will be obtained at each of these clinic follow-up visits and serum will be used to compare type III GBS specific antibody levels at baseline and follow-up; assess vaginal and rectal acquisition by GBS at months 1, 2, 4, 6, 8, 10, 12, 14, 16 and 18 months using specimens obtained at the clinic visits; compare women receiving GBS III-TT vaccine to women receiving Td vaccine with respect to the time to first vaginal culture positive for type III GBS; assess the relationship between person-level covariates, including features of the decrease of type III GBS antibody levels over time, and the time to first vaginal culture positive for type III GBS; and assess the effect of vaginal colonization by hydrogen peroxide (H2O2)-producing Lactobacillus, sexual activity, antibiotic usage, rectal colonization with GBS and demographic features as risk factors for acquisition of type III GBS, independent of serum antibody levels. The primary study endpoint will be the time to the 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. The secondary endpoints include: the proportion of vaginal swabs that are type III GBS culture positive; the proportion of subjects whose vaginal cultures are type III GBS culture negative throughout the study; the frequency of vaginal colonization with GBS serotypes Ia, Ib, II and V; the measurement of serum immunoglobulin (Ig)G antibody levels to type III GBS at 1, 2, 4, 6, 8, 10 12, 14, 16 and 18 months following vaccination; the measurement of post-vaccination antibody levels to type III GBS, stratified by pre-vaccination levels of native antibody; the frequency of local and systemic symptoms attributable to vaccination; and the density of type III GBS cultured from vaginal swabs at culture positive visits.
Interventions
BIOLOGICALGBS III-TT
50 mcg GBS Type III capsular polysaccharide conjugated to 32 mcg of tetanus toxoid. A single dose of vaccine administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml.
BIOLOGICALTetanus and diptheria toxoids vaccine
Td vaccine is a sterile solution of alum-precipitated toxoids in isotonic sodium chloride solution. A single dose of vaccine will be administered by intramuscular (IM) injection in the upper arm. All subjects will receive a volume of 0.5 ml. Each 0.5 ml dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and 2 Lf of diphtheria toxoid.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Participated in and completed the group B Streptococcus (GBS) Screening Protocol * Non-pregnant women * Aged 18-40 years at time of the screening protocol * Currently sexually active at time of enrollment (sex with a male at least once in the last 4 months) * Current use of effective birth control methods and stated intention to use the method for at least the next 30 days * Provision of written informed consent * Intention to stay in the geographical area for the next 18 months * Access to telephone
Exclusion criteria
* Group B Streptococcus (GBS) positive by culture (vaginal and/or rectal), or culture positive for streptococcal strains that cross-react with GBS typing sera (vaginal and/or rectal). * Pregnancy (all women will receive a urine pregnancy prior to vaccination). * Any condition which in the opinion of the investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine. * Serious underlying disease, which is known at the time of vaccination (including: immunodeficiency, active or chronic hepatitis, immunosuppressive conditions which require systemic steroid therapy, or treatment for a malignancy during the past year). * Receipt of any vaccine, blood product, or experimental medicine within the past 30 days with the exception of a licensed inactivated influenza vaccine. * Plans to receive any vaccine, blood product, or experimental medicine in the next 30 days with the exception of a licensed inactivated influenza vaccine. * Use of any antimicrobial agent(s) (vaginal or systemic) for treatment of any condition within 7 days prior to study enrollment (including: Monistat, Gyne-Lotrimin, et cetera ) * History of hypersensitivity to tetanus toxoid vaccine. * Tetanus toxoid immunization within the previous 12 months. * Previous participation in a study in which participants received tetanus toxoid vaccine or vaccine against Group B Streptococcus. * Spontaneous or surgical menopause. * Nursing mother. * Hypersensitivity to thimerosal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Solicited Local and Systemic Symptoms. | Safety surveillance during the 1st 7 days. | 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. |
| Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination. | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination | Prior to and 1 month following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination | Prior to and 2 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination | Prior to and 4 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination | Prior to and 6 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination | Prior to and 8 month following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination | Prior to and 10 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination | Prior to and 12 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination | Prior to and 14 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination | Prior to and 16 months following vaccination | 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. |
| Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination | Prior to and 18 months following vaccination | 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. |
| Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0 | Month 0 prior to vaccination | 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. |
| 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 | Month 1 | 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. |
| 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 | Month 2 | 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. |
| 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 | Month 4 | 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. |
| 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 | Month 6 | 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. |
| 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 | Month 8 | 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. |
| Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination. | 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. |
| 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 | Month 12 | 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. |
| 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 | Month 14 | 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. |
| 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 | Month 16 | 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. |
| 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 | Month 18 | 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. |
| Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. | Every 2 months from time of vaccination up to 18 months post-vaccination. | 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. |
| Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Every 2 months from time of vaccination up to 18 months post-vaccination. | 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. |
| Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits | Every 2 months from time of vaccination up to 18 months post-vaccination. | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | Month 0 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | Month 1 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | Month 2 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | Month 4 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | Month 6 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | Month 8 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | Month 10 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | Month 12 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | Month 14 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | Month 16 | 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. |
| The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | Month 18 | 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. |
| 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 | Month 10 | 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. |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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). | 333 |
| Td Vaccine The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). | 334 |
| Total | 667 |
Baseline characteristics
| Characteristic | Td Vaccine | GBS III-TT Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 334 Participants | 333 Participants | 667 Participants |
| Age, Continuous | 26.1 years STANDARD_DEVIATION 5.68 | 26.2 years STANDARD_DEVIATION 5.58 | 26.2 years STANDARD_DEVIATION 5.63 |
| Region of Enrollment United States | 334 participants | 333 participants | 667 participants |
| Sex: Female, Male Female | 334 Participants | 333 Participants | 667 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 304 / 326 | 320 / 337 |
| serious Total, serious adverse events | 14 / 326 | 22 / 337 |
Outcome results
Primary
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.
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT 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 4 to 6 with GBS | 1 Participants |
| GBS III-TT 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 8 to 10 censored | 8 Participants |
| GBS III-TT 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 2 to 4 with GBS | 5 Participants |
| GBS III-TT 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 10 to 12 at risk | 239 Participants |
| GBS III-TT 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 4 to 6 censored | 8 Participants |
| GBS III-TT 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 10 to 12 with GBS | 0 Participants |
| GBS III-TT 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 with GBS | 20 Participants |
| GBS III-TT 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 10 to 12 censored | 4 Participants |
| GBS III-TT 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 6 to 8 at risk | 260 Participants |
| GBS III-TT 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 12 to 14 at risk | 235 Participants |
| GBS III-TT 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 2 to 4 censored | 13 Participants |
| GBS III-TT 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 12 to 14 with GBS | 2 Participants |
| GBS III-TT 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 6 to 8 with GBS | 3 Participants |
| GBS III-TT 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 12 to 14 censored | 7 Participants |
| GBS III-TT 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 2 to 4 at risk | 287 Participants |
| GBS III-TT 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 14 to 16 at risk | 226 Participants |
| GBS III-TT 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 6 to 8 censored | 10 Participants |
| GBS III-TT 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 14 to 16 with GBS | 2 Participants |
| GBS III-TT 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 4 to 6 at risk | 269 Participants |
| GBS III-TT 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 14 to 16 censored | 4 Participants |
| GBS III-TT 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 8 to 10 at risk | 247 Participants |
| GBS III-TT 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 16 to 18 at risk | 220 Participants |
| GBS III-TT 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 censored | 18 Participants |
| GBS III-TT 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 16 to 18 with GBS | 1 Participants |
| GBS III-TT 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 8 to 10 with GBS | 0 Participants |
| GBS III-TT 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 16 to 18 censored | 185 Participants |
| GBS III-TT 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 |
| 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 16 to 18 censored | 168 Participants |
| 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 |
| 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 with GBS | 15 Participants |
| 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 censored | 15 Participants |
| 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 2 to 4 at risk | 295 Participants |
| 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 2 to 4 with GBS | 6 Participants |
| 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 2 to 4 censored | 7 Participants |
| 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 4 to 6 at risk | 282 Participants |
| 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 4 to 6 with GBS | 7 Participants |
| 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 4 to 6 censored | 7 Participants |
| 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 6 to 8 at risk | 268 Participants |
| 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 6 to 8 with GBS | 8 Participants |
| 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 6 to 8 censored | 9 Participants |
| 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 8 to 10 at risk | 251 Participants |
| 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 8 to 10 with GBS | 2 Participants |
| 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 8 to 10 censored | 6 Participants |
| 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 10 to 12 at risk | 243 Participants |
| 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 10 to 12 with GBS | 7 Participants |
| 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 10 to 12 censored | 12 Participants |
| 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 12 to 14 at risk | 224 Participants |
| 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 12 to 14 with GBS | 3 Participants |
| 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 12 to 14 censored | 3 Participants |
| 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 14 to 16 at risk | 218 Participants |
| 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 14 to 16 with GBS | 3 Participants |
| 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 14 to 16 censored | 3 Participants |
| 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 16 to 18 at risk | 212 Participants |
| 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 16 to 18 with GBS | 2 Participants |
Comparison: 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.p-value: 0.04495% CI: [1, 58]Regression, Cox
Secondary
Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination.
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.
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 4 | 9.58 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 10 | 5.80 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 2 | 12.55 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 12 | 5.16 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 6 | 7.26 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 14 | 4.80 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 1 | 12.35 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 16 | 4.57 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 8 | 6.63 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 18 | 3.99 µg/ml |
| GBS III-TT Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 0 | 0.29 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 18 | 0.27 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 0 | 0.31 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 1 | 0.29 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 2 | 0.30 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 4 | 0.29 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 6 | 0.29 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 8 | 0.26 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 10 | 0.28 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 12 | 0.27 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 14 | 0.26 µg/ml |
| Td Vaccine | Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination. | Month 16 | 0.28 µg/ml |
Secondary
Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination
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.
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 1 | 41.29 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 10 | 19.78 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 0 | 1.00 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 12 | 17.71 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 6 | 25.56 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 14 | 16.76 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 2 | 41.06 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 16 | 15.89 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 8 | 21.92 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 18 | 14.26 Ratio |
| GBS III-TT Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 4 | 31.64 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 18 | 0.92 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 0 | 1.00 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 1 | 0.99 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 2 | 0.98 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 4 | 0.93 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 6 | 0.92 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 8 | 0.89 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 10 | 0.91 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 12 | 0.91 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 14 | 0.92 Ratio |
| Td Vaccine | Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination | Month 16 | 0.90 Ratio |
Secondary
Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study.
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. | Always Vaginal Negative - False | 39 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. | Always Vaginal Negative - True | 286 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. | Always Vaginal Negative - False | 54 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study. | Always Vaginal Negative - True | 271 Participants |
Comparison: 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.p-value: 0.1295% CI: [0.917, 2.34]Fisher Exact
Secondary
Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT 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 |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits | Persistent Colonization - True | 7 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits | Persistent Colonization - False | 312 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits | Persistent Colonization - True | 13 Participants |
Comparison: 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.p-value: 0.25695% CI: [0.18, 1.45]Fisher Exact
Secondary
Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive.
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | All Clinic Visits - Positive | 80 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 18 - Missing | 61 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 1 - Negative | 313 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 1 - Positive | 7 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 2 - Missing | 8 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 2 - Negative | 303 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 2 - Positive | 14 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 4 - Missing | 24 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 4 - Negative | 292 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 4 - Positive | 9 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 6 - Missing | 25 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 6 - Negative | 293 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 6 - Positive | 7 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 8 - Missing | 34 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 8 - Negative | 282 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 8 - Positive | 9 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 10 - Missing | 41 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 10 - Negative | 279 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 10 - Positive | 5 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 12 - Missing | 48 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 12 - Negative | 272 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 12 - Positive | 5 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 14 - Missing | 52 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 14 - Negative | 268 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 14 - Positive | 5 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 16 - Missing | 58 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 16 - Negative | 260 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 16 - Positive | 7 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 18 - Negative | 256 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 18 - Positive | 7 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | All Clinic Visits - Missing | 356 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | All Clinic Visits - Negative | 3138 Participants |
| GBS III-TT Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 1 - Missing | 5 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | All Clinic Visits - Negative | 3126 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 16 - Positive | 12 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 10 - Missing | 38 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | All Clinic Visits - Positive | 125 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 1 - Missing | 2 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 14 - Positive | 15 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 1 - Negative | 314 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 10 - Negative | 273 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 1 - Positive | 9 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 18 - Negative | 255 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 2 - Missing | 7 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 10 - Positive | 14 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 2 - Negative | 310 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 16 - Missing | 56 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 2 - Positive | 8 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 12 - Missing | 42 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 4 - Missing | 15 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | All Clinic Visits - Missing | 324 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 4 - Negative | 301 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 12 - Negative | 266 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 4 - Positive | 9 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 16 - Negative | 257 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 6 - Missing | 22 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 12 - Positive | 17 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 6 - Negative | 291 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 18 - Positive | 8 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 6 - Positive | 12 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 14 - Missing | 51 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 8 - Missing | 29 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 18 - Missing | 62 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 8 - Negative | 279 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 14 - Negative | 259 Participants |
| Td Vaccine | Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive. | Month 8 - Positive | 17 Participants |
Comparison: 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.p-value: 0.08995% CI: [-7, 61]Binomial regression, log-linear link
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 1 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 2 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 3 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 2 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 1 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 1 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 1 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 2 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 1 participants |
Secondary
Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 1 participants |
Secondary
Number of Participants With Any Solicited Local and Systemic Symptoms.
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.
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Local Swelling | 23 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Elevated Oral Temperature (>37.4 degrees Celsius) | 33 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Any Solicited Local Symptom | 251 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Malaise (Decreased energy) | 103 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Local Redness | 27 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Myalgia (General muscle aches) | 91 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Chills | 30 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Nausea | 55 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Local Tenderness at Injection Site | 234 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Any Solicited Systemic Symptom | 208 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Headache | 130 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Any Solicited Symptom | 282 Participants |
| GBS III-TT Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | General Arm Pain | 175 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Any Solicited Symptom | 307 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | General Arm Pain | 223 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Local Redness | 40 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Local Swelling | 52 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Local Tenderness at Injection Site | 276 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Any Solicited Local Symptom | 294 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Chills | 33 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Headache | 118 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Elevated Oral Temperature (>37.4 degrees Celsius) | 32 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Malaise (Decreased energy) | 111 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Myalgia (General muscle aches) | 112 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Nausea | 61 Participants |
| Td Vaccine | Number of Participants With Any Solicited Local and Systemic Symptoms. | Any Solicited Systemic Symptom | 206 Participants |
Secondary
Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 18 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 10 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 10 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 9 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 8 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 9 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 12 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 13 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 12 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 11 participants |
Secondary
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
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GBS III-TT 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 |
| 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 | 9 participants |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 0
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | Broth only | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 2+ | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | Negative | 321 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 1+ | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 4+ | 4 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 3+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 4+ | 4 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | Negative | 320 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | Broth only | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 2+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 0 | 3+ | 0 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 1
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | Broth only | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 2+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 3+ | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | Negative | 314 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 4+ | 5 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 4+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | Negative | 313 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | Broth only | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 1+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 3+ | 3 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 1 | 2+ | 1 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 10
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | Broth only | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | Negative | 273 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 3+ | 3 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 1+ | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 4+ | 6 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 2+ | 3 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 4+ | 3 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | Negative | 279 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | Broth only | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 2+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 10 | 3+ | 0 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 12
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | Broth only | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 2+ | 3 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 3+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | Negative | 266 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 4+ | 11 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 4+ | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | Negative | 272 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | Broth only | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 3+ | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 12 | 2+ | 1 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 14
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | Negative | 259 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | Broth only | 3 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 1+ | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 2+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 3+ | 4 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 4+ | 5 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 3+ | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | Negative | 268 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 2+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | Broth only | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 4+ | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 14 | 1+ | 1 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 16
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 2+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | Negative | 257 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 3+ | 3 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 1+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 4+ | 5 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | Broth only | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 4+ | 4 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | Broth only | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 1+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 2+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | 3+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 16 | Negative | 260 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 18
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | Broth only | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | Negative | 255 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 1+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 2+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 3+ | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 4+ | 4 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 3+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 2+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | Negative | 256 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | Broth only | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 4+ | 4 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 18 | 1+ | 0 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 2
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 2+ | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | Negative | 310 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | Broth only | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 1+ | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 3+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 4+ | 5 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 3+ | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 2+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 1+ | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | Negative | 303 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | 4+ | 9 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 2 | Broth only | 1 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 4
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | Broth only | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | Negative | 301 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 1+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 2+ | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 3+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 4+ | 3 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 3+ | 3 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 2+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | Negative | 292 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | Broth only | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 4+ | 4 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 4 | 1+ | 2 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 6
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | Broth only | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 2+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | Negative | 291 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 3+ | 2 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 4+ | 8 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 4+ | 3 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | Negative | 293 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | Broth only | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 2+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 6 | 3+ | 2 Swabs |
Secondary
The Density of Type III GBS Cultured From Vaginal Swabs at Month 8
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | Broth only | 3 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 2+ | 0 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | Negative | 279 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 3+ | 1 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 4+ | 13 Swabs |
| GBS III-TT Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 4+ | 4 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | Negative | 282 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | Broth only | 1 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 1+ | 0 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 2+ | 2 Swabs |
| Td Vaccine | The Density of Type III GBS Cultured From Vaginal Swabs at Month 8 | 3+ | 2 Swabs |