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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

Total of all reporting groups

The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).

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.

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.

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.

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).

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.

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

Blood samples were collected from participants 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Blood samples were collected from participants 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.