A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

Completed · Phase 3

Conditions studied: Respiratory Syncytial Virus Prevention

In brief

The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.

Key facts

Study ID

NCT05101486

Run by

Janssen Vaccines & Prevention B.V.

People needed

755

Starts

2021-11-01

Expected to finish

2022-09-20

Last updated by the study team

2025-05-25

Who can join

Age: 60 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• From the time of vaccination through 3 months after vaccination, agrees not to donate blood
• In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
• Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
• Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• Must be able to work with smartphones/tablets/computers

You may not qualify if…

• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
• Abnormal function of the immune system resulting from clinical conditions or medication
• Per medical history, participant has chronic active hepatitis B or hepatitis C infection
• History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
• Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
• Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures

Where it is running

• North Alabama Research Center, LLC — Athens, Alabama, United States
• Achieve Clinical Research, LLC — Vestavia Hills, Alabama, United States
• Hope Research Institute — Phoenix, Arizona, United States
• Clinical Research Consulting — Milford, Connecticut, United States
• Accel Research Sites — DeLand, Florida, United States
• Pharmax Research Clinic Inc — Miami, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• Suncoast Research Associates, LLC — Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• Be Well Clinical Studies — Lincoln, Nebraska, United States
• American Health Network, LLC — Charlotte, North Carolina, United States
• CTI Clinical Trial and Consulting Services — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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