NCT03982199

A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5,815 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.

Conditions

• Respiratory Syncytial Viruses
• Respiratory Tract Diseases

Interventions

Type	Name	Description
BIOLOGICAL	RSV Vaccine	Participants will receive a single IM injection of an Ad26-based RSV vaccine at a single dose level on Day 1 and revaccination after either 1 year, 2 years, or 3 years.
BIOLOGICAL	Placebo	Participants will receive a single IM injection of placebo control on Day 1.

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-06-06
• Completion: 2023-05-26
• First posted: 2019-06-11
• Last updated: 2025-05-25
• Results posted: 2023-07-24

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study