Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSVPreF3 OA investigational vaccine
Intervention description: RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open-label study. Both investigator and participant know the identity of the intervention assigned.
Enrollment: 1720.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory syncytial virus; Vaccine; Safety; Reactogenicity; Immunogenicity

Summary:

      The purpose of this study is to assess the safety, reactogenicity, immunogenicity and
      long-term persistence of immune response up to 3 years following a single dose vaccination of
      GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will
      also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given
      according to different revaccination schedules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants ≥60 YOA at first vaccination, who live in the community
             (CD participants) or in a Long-term care facility (LTCF participants).

          -  Participants who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  Written or witnessed informed consent obtained from the participant prior to
             performance of any study specific procedure.

          -  Participants who are medically stable in the opinion of the investigator at the time
             of first vaccination. Patients with chronic stable medical conditions with or without
             specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to
             participate in this study if considered by the investigator as medically stable.

        Exclusion Criteria:

        Medical conditions

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
             from disease or immunosuppressive/cytotoxic therapy, based on medical history and
             physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Hypersensitivity to latex.

          -  Serious or unstable chronic illness.

          -  Recurrent or un-controlled neurological disorders or seizures. Participants with
             medically-controlled active or chronic neurological diseases can be enrolled in the
             study as per investigator assessment, provided that their condition will allow them to
             comply with the requirements of the protocol.

          -  Significant underlying illness that in the opinion of the investigator would be
             expected to prevent completion of the study.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.

          -  Any history of dementia or any medical condition that moderately or severely impairs
             cognition.

        Prior/Concomitant therapy

          -  Use of any investigational or non-registered product other than the study vaccine
             during the period beginning 30 days before the first dose of study vaccine, or planned
             use during the study period.

          -  Planned or actual administration of a vaccine not foreseen by the study protocol in
             the period starting 30 days before each dose and ending 30 days after each dose of
             study vaccine administration, with the exception of inactivated, split virion and
             subunit influenza vaccines which can be administered up to 14 days before or from 14
             days after each study vaccination.

          -  Previous vaccination with an RSV vaccine.

          -  Administration of long-acting immune-modifying drugs or planned administration at any
             time during the study period.

          -  Administration of immunoglobulins and/or any blood products or plasma derivatives
             during the period starting 90 days before the first dose of study vaccine or planned
             administration during the study period.

          -  Chronic administration (defined as more than 14 consecutive days in total) of
             immunosuppressants or other immune-modifying drugs during the period starting 90 days
             prior to the first vaccine dose or planned administration during the study period. For
             corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and
             topical steroids are allowed.

        Prior/Concurrent clinical study experience

        • Concurrently participating in another clinical study, at any time during the study
        period, in which the participant has been or will be exposed to an investigational or a
        non-investigational vaccine/product.

        Other exclusions

          -  History of chronic alcohol consumption and/or drug abuse as deemed by the investigator
             to render the potential participant unable/unlikely to provide accurate safety reports
             or comply with study procedures.

          -  Bedridden participants.

          -  Planned move during the study period that will prohibit participation in the trial
             until the study end. This includes:

               -  Planned move during the study period to another LTCF that will prohibit
                  participation in the trial until study end.

               -  Planned move from the community to a LTCF that will prohibit participation in the
                  trial until study end.

          -  Participation of any study personnel or their immediate dependants, family, or
             household members.