Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSVPreF3 OA investigational vaccine (GSK3844766A)
Intervention description: RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: This is an open-label study, as all participants will receive the same RSVPreF3 OA investigational vaccine. No blind is used. Both the investigator and the participant know the identity of the intervention assigned.
Enrollment: 126.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory syncytial virus; Vaccine; Safety; Immunogenicity

Summary:

      Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the
      parent study (NCT03814590). Based on safety and immunogenicity data from the parent study,
      RSVPreF3 OA investigational vaccine will be evaluated in further clinical research.
      Participants in selected groups will be invited to participate in this extension study. All
      participants who will be enrolled in the current extension study will receive the RSV
      investigational vaccine approximately 18 months after they received their respective dose-2
      in the parent study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, who received 2 doses of RSVPreF3 OA investigational
             vaccine and formulations with matched adjuvant in part B of the parent study RSV
             OA=ADJ-002: recombinant RSVPreF3 antigen doses of low, medium and high strengths with
             adjuvant.

          -  Participants who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol (e.g. completion of the diary cards, return for the
             follow-up visit, be available for contact)

          -  Written informed consent obtained from the participant prior to performance of any
             study specific procedure.

        Exclusion Criteria:

        Medical conditions

          -  Significant underlying illness or administered therapy that in the opinion of the
             investigator would be expected to prevent participation in the study.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             information on concomitant medication/vaccination collected prior to the study start
             and physical examination.

          -  Serious or unstable chronic illness that developed during or after the parent study.
             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 clinically stable.

          -  Recurrent or un-controlled neurological disorders or seizures that developed during or
             after the parent study. 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 developed during or after the parent study, that
             in the opinion of the investigator would be expected to prevent completion of the
             study.

          -  Lymphoproliferative disorder and malignancy developed during or after the parent
             study.

          -  Any medical condition that developed during or after the parent study, that in the
             judgment of the investigator would make intramuscular injection unsafe.

          -  Previous vaccination with RSV vaccine, other than the one in the parent study.

        Prior/Concomitant therapy

          -  Use of any investigational or non-registered product (drug, vaccine or medical device)
             other than the study vaccine during the period beginning 30 days before the 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 and ending 30 days after the 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 30 days after the
             study vaccination.

          -  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 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 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.

          -  Confirmed use or anticipated use of immunosuppressive/cytotoxic therapy.

        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

          -  Bedridden participants.

          -  Planned move to a location that will prohibit participating in the trial.

          -  History of chronic alcohol consumption and/or drug abuse that developed during or
             after the parent study as deemed by the investigator to render the potential
             participant unable/unlikely to provide accurate safety reports or comply with study
             procedures.