CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 669 enrolled
Drug / intervention
Placebo +8 morebiological
Likely dose
RSV preF Protein 50 mcgfrom 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/NCT03502707
NCT03502707Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

Janssen Vaccines & Prevention B.V.·interventional·Posted Apr 19, 2018·Updated May 25, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo, RSV preF Protein 50 mcg, and 7 other interventions for Healthy. Completed, enrolled 669 participants across 6 sites.

Detailed Summary

The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 19, 2018
Enrollment StartJul 6, 2018
Primary CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.2 years ago

Interventions

Placebobiological

Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.

RSV preF Protein 50 mcgbiological

RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.

RSV preF Protein 150 mcgbiological

RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.

Ad26.RSV.preF 1*10^11 vpbiological

Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.

Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcgbiological

Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.

Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcgbiological

Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.

Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcgbiological

Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.

Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcgbiological

Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.

Selected Regimenbiological

A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.