A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Timeline

Start

2017-01-11

Primary completion

2019-02-19

Completion

2020-11-26

Publications

• Diez-Domingo J, Saez-Llorens X, Rodriguez-Weber MA, Epalza C, Chatterjee A, Chiu CH, Lin CY, Berry AA, Martinon-Torres F, Baquero-Artigao F, Langley JM, Ramos Amador JT, Domachowske JB, Huang LM, Chiu NC, Esposito S, Moris P, Lien-Anh Nguyen T, Nikic V, Woo W, Zhou Y, Dieussaert I, Leach A, Gonzalez Lopez A, Vanhoutte N. Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus (RSV) Vaccine in Healthy RSV-Seropositive Children 12-23 Months of Age. J Infect Dis. 2023 May 29;227(11):1293-1302. doi: 10.1093/infdis/jiac481.

Drugs

Indications