A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age

Summary

The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5\*10\^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.

Timeline

Start

2019-01-21

Primary completion

2021-11-02

Completion

2021-11-02

Publications

• Langley JM, Nolan TM, Ramet M, Richmond PC, Rosario Filho N, Haazen W, van den Berg SPH, Williams K, Bastian AR, Omoruyi E, Williams Durkin J, Salisch N, Van Geet G, van Duijnhoven W, Heijnen E, Callendret B. A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months. Open Forum Infect Dis. 2024 Aug 8;11(9):ofae453. doi: 10.1093/ofid/ofae453. eCollection 2024 Sep.

Drugs

Indications