CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25,236 enrolled
Drug / intervention
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04908683
NCT04908683Phase 3Completed
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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

Janssen Vaccines & Prevention B.V.·interventional·Posted Jun 1, 2021·Updated Nov 13, 2025

In Brief

A Phase 3 clinical trial evaluating Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF and Placebo for Respiratory Syncytial Viruses and Lower Respiratory Tract Disease. Completed, enrolled 25,236 participants across 272 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Viruses, Lower Respiratory Tract Disease
CountriesAustralia, Brazil, Canada, Chile, China, Estonia, Finland, New Zealand, Poland, South Africa, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJun 1, 2021
Enrollment StartJul 21, 2021
Primary CompletionJul 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 5.1 years ago

Interventions

Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preFbiological

Participants will receive a single IM injection of an RSV vaccine.

Placebobiological

Participants will receive a single IM injection of matching placebo.