NCT05242432

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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Efficacy, Safety, Reactogenicity, and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Japanese Adults Aged 60 Years and Older, and Safety, Reactogenicity, and Immunogenicity of the Vaccine in Japanese Adults Aged 20 to 59 Years at High-risk of RSV Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,192 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Syncytial Virus Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Ad26/protein preF RSV Vaccine	Ad26/protein preF RSV vaccine will be administered as an IM injection.
OTHER	Placebo	Matching Placebo will be administered as an IM injection

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-03-20
• Completion: 2023-03-20
• First posted: 2022-02-16
• Last updated: 2025-05-23

Locations

30 sites across 1 country: Japan