NCT04908683

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25,236 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Conditions

• Respiratory Syncytial Viruses
• Lower Respiratory Tract Disease

Interventions

Type	Name	Description
BIOLOGICAL	Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF	Participants will receive a single IM injection of an RSV vaccine.
BIOLOGICAL	Placebo	Participants will receive a single IM injection of matching placebo.

Timeline

• Start date: 2021-07-21
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2021-06-01
• Last updated: 2025-11-13
• Results posted: 2024-02-08

Locations

272 sites across 14 countries: United States, Australia, Brazil, Canada, Chile, China, Estonia, Finland, New Zealand, Poland, South Africa, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study