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
Condition: Respiratory Syncytial Viruses; Respiratory Tract Diseases
MeSH terms: Respiratory Tract Diseases
Intervention: RSV Vaccine; Placebo
Intervention description: Participants will receive a single IM injection of an Ad26-based RSV vaccine at a single dose level on Day 1 and revaccination after either 1 year, 2 years, or 3 years.; Participants will receive a single IM injection of placebo control on Day 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 5815.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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)