A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

Summary

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.

Timeline

Start

2019-11-05

Primary completion

2020-02-25

Completion

2021-11-22

Publications

• Background Hermida N, Ferguson M, Leroux-Roels I, Pagnussat S, Yaplee D, Hua N, van den Steen P, Anspach B, Dieussaert I, Kim JH. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. J Infect Dis. 2024 Aug 16;230(2):e353-e362. doi: 10.1093/infdis/jiad560.

Drugs

Indications