A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older

Phase 1 Completed 36 enrolled Janssen Pharmaceutical K.K.

RandomizedParallel-groupTriple-blindPrevention

Summary

The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.

Timeline

Start: 2020-05-15
Primary completion: 2021-01-20
Completion: 2021-01-20

Publications

Eto T, Okubo Y, Momose A, Tamura H, Zheng R, Callendret B, Bastian AR, Comeaux CA. A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older. Influenza Other Respir Viruses. 2024 Jun;18(6):e13336. doi: 10.1111/irv.13336.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.RSV.preF	Vaccine	150 ug	Intramuscular
Subject	Ad26.RSV.preF	Vaccine	1e+11 vg	Intramuscular

Indications

No indication recorded.