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

NCT04453202 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2025-05-25

Study results available
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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

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.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2020-09-24
Completion
2021-04-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04453202 on ClinicalTrials.gov