Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants

Summary

The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

Timeline

Start

2019-11-05

Primary completion

2020-07-23

Completion

2021-05-14

Publications

• Bebia Z, Reyes O, Jeanfreau R, Kantele A, De Leon RG, Sanchez MG, Banooni P, Gardener GJ, Rasero JLB, Pardilla MBE, Langley JM, Di Leo CM, Botelho-Nevers E, Buttery J, Laurichesse H, Madhi SA, Garcia AM, Stanley T, Barjat T, Griffith R, Castrejon-Alba MM, de Heusch M, Dieussaert I, Hercor M, Lese P, Qian H, Tullio AN, Henry O. Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. J Infect Dis. 2023 Aug 11;228(3):299-310. doi: 10.1093/infdis/jiad024.

Drugs

Indications