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A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection

NCT05070546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1124

Last updated 2025-05-25

Study results available
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Summary

The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.

Conditions

  • Respiratory Syncytial Virus Infection Prevention

Interventions

BIOLOGICAL

Ad26.RSV.preF-based Vaccine

Participants will receive a single IM injection of an RSV vaccine.

OTHER

Placebo

Participants will receive a single IM injection of matching placebo.

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-29
Primary Completion
2022-08-12
Completion
2022-08-12
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Spain
  • Sweden

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 NCT05070546 on ClinicalTrials.gov