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

A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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