A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Viruses, Respiratory Tract Diseases

In brief

The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.

Key facts

Study ID: NCT03982199
Run by: Janssen Vaccines & Prevention B.V.
People needed: 5815
Starts: 2019-08-01
Expected to finish: 2023-05-26
Last updated by the study team: 2025-05-25

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Participant must have a body mass index (BMI) less than (<)40 kilogram per meter square (kg/m\^2)
Before randomization, a woman must be: postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
Participant must be either in good or stable health. Participants may have mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung disease (asthma and chronic obstructive pulmonary disease [COPD]), congestive heart failure (CHF), hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination on Day 1
From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
Participant must be able to read, understand, and complete questionnaires in the eDiary (or a paper safety diary, if designated by the sponsor)
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

You may not qualify if…

Participant has an acute illness (including acute respiratory illnesses) or body temperature greater than or equal to (>=)38.0 degree Celsius (ºC) within 24 hours prior to administration of study vaccine. In such a situation, enrollment at a later date is permitted
Participant has a severe or potentially life-threatening chronic disorder such as severe chronic cardiac diseases and severe chronic lung disease (asthma and COPD), advanced CHF, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any 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, limit, or confound the protocol-specified assessments
Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Per medical history, participant has chronic active hepatitis B or hepatitis C infection
Per medical history, participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
Participant has a known 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

Optimal Research — Huntsville, Alabama, United States
Synexus Clinical Research US Inc — Chandler, Arizona, United States
Synexus Clinical Research US Inc — Phoenix, Arizona, United States
Central Phoenix Medical Clinic — Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC — Anaheim, California, United States
Paradigm Clinical Research Centers, Inc. — Redding, California, United States
Benchmark Research — Sacramento, California, United States
Optimal Research — San Diego, California, United States
Synexus Clinical Research US Inc — Aurora, Colorado, United States
Lynn Institute — Colorado Springs, Colorado, United States
Optimal Research — Melbourne, Florida, United States
Advanced Clinical Research — Boise, Idaho, United States
Optimal Research — Peoria, Illinois, United States
Synexus Clinical Research US Inc — Evansville, Indiana, United States
The Iowa Clinic — West Des Moines, Iowa, United States
Hutchinson Clinic — Hutchinson, Kansas, United States
Johnson County Clin-Trials — Lenexa, Kansas, United States
Heartland Research Associates, LLC — Newton, Kansas, United States
Heartland Research Associates, LLC — Wichita, Kansas, United States
Optimal Research — Rockville, Maryland, United States
Synexus Clinical Research US Inc — Richfield, Minnesota, United States
The Center For Pharmaceutical Research — Kansas City, Missouri, United States
Sundance Clinical Research — St Louis, Missouri, United States
Synexus Clinical Research US Inc — St Louis, Missouri, United States
Synexus Clinical Research US Inc — Elkhorn, Nebraska, United States

Full record on ClinicalTrials.gov

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