CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 777 enrolled
Drug / intervention
Ad26.RSV.preF-based vaccine +2 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/NCT05071313
NCT05071313Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older

Janssen Vaccines & Prevention B.V.·interventional·Posted Oct 8, 2021·Updated May 25, 2025

In Brief

A Phase 3 clinical trial evaluating Ad26.RSV.preF-based vaccine, Quadrivalent High-dose Influenza Vaccine, and 1 other intervention for Influenza, Human Prevention and Respiratory Syncytial Viruses Prevention. Completed, enrolled 777 participants across 19 sites.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human Prevention, Respiratory Syncytial Viruses Prevention
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 8, 2021
Enrollment StartOct 4, 2021
Primary CompletionApr 20, 2022
Study CompletionOct 11, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.7 years ago

Interventions

Ad26.RSV.preF-based vaccinebiological

Ad26.RSV.preF-based vaccine will be administered as single IM injection.

Quadrivalent High-dose Influenza Vaccinebiological

Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.

Placebobiological

Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.