A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
Condition: Respiratory Syncytial Viruses; Lower Respiratory Tract Disease
MeSH terms: Respiratory Tract Diseases
Intervention: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF; Placebo
Intervention description: Participants will receive a single IM injection of an RSV vaccine.; Participants will receive a single IM injection of matching placebo.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25236.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acute Respiratory Infections; Vaccine; Ad26.RSV.preF-based Vaccine

Summary:

      The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the
      active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription
      Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower
      Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to work with smartphones/tablets/computers

          -  From the time of vaccination through 3 months after vaccination, participant agrees
             not to donate blood

          -  Must be willing to provide verifiable identification, has means to be contacted and to
             contact the investigator during the study

          -  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

          -  Participants must sign an Inform Consent Form (ICF) indicating that the participant
             understands the purpose, procedures and potential risks and benefits of the study, and
             is willing to participate in the study

        Exclusion Criteria:

          -  Has a serious clinically unstable condition, (example, end-stage renal disease with or
             without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any
             other 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, confound, or limit the protocol specified assessments

          -  History of malignancy within 5 years before screening not in the following categories:
             a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in
             situ of the cervix may be enrolled at the discretion of the investigator; b.
             Participants with a history of malignancy within 5 years, which is considered cured
             with minimal risk of recurrence per investigator's judgement, can be enrolled

          -  Had major surgery (example, major cardiopulmonary or abdominal operations) as per the
             investigator's judgment within 4 weeks before vaccination, or will not have fully
             recovered from surgery, or has major surgery planned during the time the participant
             is expected to participate in the study

          -  Employee of the investigator or study site, with direct involvement in the proposed
             study or other studies under the direction of that investigator or study site, as well
             as family members of the employees or the investigator, or an employee of the sponsor

          -  Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding
             disorders)

          -  Known or suspected allergy or history of anaphylaxis or other serious adverse
             reactions to vaccines or vaccine components (including any of the constituents of the
             study vaccine)