A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants

Summary

The purpose of the study is to evaluate the efficacy of study vaccine in the prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-confirmed RSV mediated- lower Respiratory Tract Disease (LRTD) over one RSV season when compared to placebo in adults aged 60 years and above and to demonstrate the non-inferiority of the vaccine in high-risk adults aged 20 to 59 years versus in adults aged 60 years and older in terms of humoral immune response.

Timeline

Start

2022-04-01

Primary completion

2023-03-20

Completion

2023-03-20

Outcome

Outcome not reported

Stopped (Business): “Terminated (Janssen made the strategic decision to discontinue the RSV3007 study. This decision is not based on any safety concerns.)”

Publications

• Tamura H, Momose A, Takato Y, Richuan Z, Bastian AR, Callendret B, Heijnen E. Phase 3 study of an Ad26.RSV.preF/RSV preF protein vaccine to evaluate the prevention efficacy of RSV-mediated lower tract disease, immunogenicity and safety in Japanese adults. Respir Investig. 2025 Jul;63(4):560-568. doi: 10.1016/j.resinv.2025.04.016. Epub 2025 May 3.

Drugs

Indications