A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
Condition: Respiratory Syncytial Virus Infection Prevention
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Intervention: Ad26.RSV.preF-based Vaccine; 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: 1124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF
      based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe
      Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be of a) non child bearing potential or b) of child bearing
             potential and practicing an acceptable and effective of contraception

          -  All participants of childbearing potential must: have a negative highly sensitive
             urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; and
             have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to
             each study vaccination (if screening and vaccination are not performed on the same
             day) Cohorts 1 and 2

          -  Participant is aged 18 to 59 years (inclusive) on the day of signing the informed
             consent form (ICF) and expected to be available for the duration of the study Cohort 2

          -  Has an existing chronic heart or lung condition, without hospitalizations or major
             medication class change (that is, new or stopped medications) within 30 days prior to
             screening, meeting the following criteria; a) cardiac disease: at least Class II
             symptoms per New York Heart Association classification or similar guidelines according
             to local practice, b) pulmonary disease: activity-restricting symptoms or use of
             long-term medications Cohort 3

          -  Participant is aged 65 years or older on the day of signing the ICF and expected to be
             available for the duration of the study

          -  Participant may have underlying illnesses such as hypertension, congestive heart
             failure, chronic obstructive pulmonary disease (COPD), 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

        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 immune system due to a clinical condition or treatment

          -  History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced
             thrombocytopenia and thrombosis (HITT).

          -  Participant received or plans to receive: (a) licensed live attenuated vaccines -
             within 28 days before or after planned administration of study vaccine; and (b) other
             licensed (not live) vaccines - within 14 days before or after planned administration
             of study vaccine

          -  Received an respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study

          -  History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic
             idiopathic demyelinating polyneuropathy