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

Completed · Phase 3 · Has a placebo group

Conditions studied: Respiratory Syncytial Viruses, Lower Respiratory Tract Disease

In brief

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.

Key facts

Study ID

NCT04908683

Run by

Janssen Vaccines & Prevention B.V.

People needed

25236

Starts

2021-07-21

Expected to finish

2023-07-21

Last updated by the study team

2025-11-13

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be able to work with smartphones/tablets/computers
• From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
• Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• Before randomization, a participant must be: a. postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b. not intending to conceive by any methods
• Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

You may not qualify if…

• Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
• History of malignancy within 5 years before screening not in the following categories: a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
• Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
• Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
• Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)

Where it is running

• Synexus Clinical Research US Inc — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Optimal Research — Huntsville, Alabama, United States
• Coastal Clinical Research, Inc — Mobile, Alabama, United States
• Synexus Clinical Research US Inc — Chandler, Arizona, United States
• Hope Research Institute — Peoria, Arizona, United States
• Central Phoenix Medical Clinic — Phoenix, Arizona, United States
• Medpharmics, LLC — Phoenix, Arizona, United States
• Clinical Research Consortium Arizona — Tempe, Arizona, United States
• Synexus Clinical Research US Inc — Tucson, Arizona, United States
• Baptist Health Center For Clinical Research — Little Rock, Arkansas, United States
• Rancho Paseo Medical Group — Banning, California, United States
• Hope clinical Research LLC — Canoga Park, California, United States
• Synexus Clinical Research US Inc — Cerritos, California, United States
• eStudySite — Chula Vista, California, United States
• Velocity Clinical Research, San Diego — La Mesa, California, United States
• Paradigm Clinical Research Centers, Inc. — Redding, California, United States
• Optimal Research — San Diego, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Synexus Clinical Research US Inc — Vista, California, United States
• Synexus Clinical Research US Inc — Aurora, Colorado, United States
• Tekton Research Inc. — Fort Collins, Colorado, United States
• Tekton Research Inc. — Longmont, Colorado, United States
• Paradigm Clinical Research Centers, Inc. — Wheat Ridge, Colorado, United States
• Central Research Associates, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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