CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Ad26.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/NCT03334695
NCT03334695Phase 2Completed
CompareCT.gov

An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults

Janssen Vaccines & Prevention B.V.·interventional·Posted Nov 7, 2017·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating Ad26.RSV.preF and Placebo for Healthy. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1\*10\^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 7, 2017
Enrollment StartOct 16, 2017
Primary CompletionJul 10, 2018
Study CompletionNov 27, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.7 years ago

Interventions

Ad26.RSV.preFbiological

Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp in single-use vials.

Placebodrug

Placebo will be administered as sterile 0.9% saline for injection.