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A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

NCT04908683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25236

Last updated 2025-11-13

Study results available
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Summary

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Conditions

  • Respiratory Syncytial Viruses
  • Lower Respiratory Tract Disease

Interventions

BIOLOGICAL

Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF

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

BIOLOGICAL

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
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2023-07-21
Completion
2023-07-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • Estonia
  • Finland
  • New Zealand
  • Poland
  • South Africa
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04908683 on ClinicalTrials.gov