This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.
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Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination
Timeframe: Day 1 (day of vaccination) to Day 7
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination
Timeframe: Day 1 (day of vaccination) to Day 7
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination
Timeframe: Day 1 (day of vaccination) through 1 Month post-vaccination
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination
Timeframe: Day 1 (day of vaccination) through 6 Months post-vaccination
Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups
Timeframe: 1 Month after Vaccination (Day 1, day of vaccination)
Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination
Timeframe: 1 Month after Vaccination (Day 1, day of vaccination)
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination
Timeframe: 1 Month after Vaccination (Day 1, day of vaccination)