A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Condition: Respiratory Syncytial Virus Prevention
Intervention: Ad26.RSV.PreF-based Vaccine
Intervention description: Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 755.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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