Trials / Completed

CompletedNCT04453202

A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 459 (actual)

Sponsor: Janssen Vaccines & Prevention B.V. · Industry
Sex: All
Age: 60 Years
Healthy volunteers: Accepted

Summary

The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).

Conditions

Healthy

Interventions

Type	Name	Description
BIOLOGICAL	RSV Vaccine	Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
OTHER	Placebo	Participants will receive a single IM injection of placebo on Day 1.

Timeline

Start date: 2020-07-16
Primary completion: 2020-09-24
Completion: 2021-04-09
First posted: 2020-07-01
Last updated: 2025-05-25
Results posted: 2023-10-03

Locations

9 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04453202. Inclusion in this directory is not an endorsement.