CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Ad26.RSV.preF (1*10^11 vp) +2 morebiological
Likely dose
Ad26.RSV.preF (5*10^10 vp) 0.25 mLfrom 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/NCT03303625
NCT03303625Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age

Janssen Vaccines & Prevention B.V.·interventional·Posted Oct 6, 2017·Updated May 25, 2025

In Brief

A Phase 2 clinical trial evaluating Ad26.RSV.preF (1*10^11 vp), Ad26.RSV.preF (5*10^10 vp), and 1 other intervention for Respiratory Syncytial Viruses and Respiratory Tract Infections. Completed, enrolled 48 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Viruses, Respiratory Tract Infections
CountriesFinland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 6, 2017
Enrollment StartNov 29, 2017
Primary CompletionApr 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.7 years ago

Interventions

Ad26.RSV.preF (1*10^11 vp)biological

Participants will receive two doses of 0.5 milliliter (mL) (1\*10\^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

Ad26.RSV.preF (5*10^10 vp)biological

RSV seropositive participants will receive two doses of 0.25 mL (5\*10\^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

Placebodrug

Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.