Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

Summary

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.

Timeline

Start

2022-08-12

Primary completion

2023-04-27

Completion

2023-04-27

Publications

• Smith WB, Seger W, Chawana R, Skogeby Z, Silmon de Monerri NC, Feng Y, Gaylord M, Jongihlati B, Beeslaar J, Skinner JM, Bickham K, Anderson AS. A Phase 2b Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 6-Valent Group B Streptococcus Vaccine Administered Concomitantly With Tetanus, Diphtheria, and Acellular Pertussis Vaccine in Healthy Nonpregnant Female Individuals. J Infect Dis. 2025 Jul 11;231(6):e1065-e1074. doi: 10.1093/infdis/jiaf096.

Drugs

Indications