A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
Condition: Respiratory Syncytial Virus Prevention
Intervention: Ad26.RSV.preF-based vaccine
Intervention description: Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate non-inferiority in terms of humoral immune
      responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM)
      compared with one dose of the Phase 2b CTM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to adhere to the prohibitions and restrictions specified in the
             protocol

          -  Before randomization, a participant 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

          -  In the investigator's clinical judgment, 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 willing to provide verifiable identification, has means to be contacted and to
             contact the investigator during the study

          -  From the time of vaccination through 3 months after vaccination, agrees not to donate
             blood

        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 condition or medication

          -  History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic
             idiopathic demyelinating polyneuropathy

          -  History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced
             thrombocytopenia and thrombosis (HITT)

          -  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