A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B; Placebo
Intervention description: Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.; Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2
      doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of
      lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  Written informed consent obtained from the subject prior to performance of any study
             specific procedure.

          -  A male or female between, and including, 60 and 80 years of age at the time of the
             first vaccination.

          -  Subjects with residence status allowing free mixing with general community or in an
             assisted-living facility that provides minimal assistance, such that the subject is
             primarily responsible for self-care and activities of daily living, may be enrolled.

          -  Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese
             grandparents and able to speak Japanese).

          -  Subject satisfying screening requirements.

        Exclusion Criteria:

        Medical conditions

          -  Any medical condition that in the judgment of the investigator would make IM injection
             unsafe.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Hypersensitivity to latex.

          -  Serious or unstable chronic illness. Patients with chronic stable conditions with or
             without specific treatment, such as diabetes, hypertension or cardiac disease, are
             allowed to participate in this study.

          -  Any other condition that, in the opinion of the investigator, might interfere with the
             evaluations required by the study.

          -  History of any neurological disorders or seizures.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by the investigator based on medical history,
             physical examination or laboratory screening tests.

          -  Hepatomegaly, right upper quadrant abdominal pain or tenderness.

          -  Significant underlying illness that in the opinion of the investigator would be
             expected to prevent completion of the study.

          -  Lymphoproliferative disorder and malignancy within 5 years.

          -  At screening: Hematology parameters (complete blood cell count [red blood cells, WBC],
             white blood cells differential count [lymphocytes, neutrophils and eosinophils],
             platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood
             urea nitrogen or liver enzymes [ALT or AST]) outside the normal laboratory ranges,
             unless the laboratory abnormalities are considered not clinically significant by the
             investigator.

        Prior/Concomitant therapy

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine during the period starting 30 days before the first dose of study
             vaccine (Day -29 to Day 1), or planned use during the study period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose and ending 30 days after the last
             dose of study vaccine administration, with the exception of inactivated and subunit
             influenza vaccines which can be administered up to 14 days before or from 30 days
             after each study vaccination.

          -  Previous vaccination with an RSV vaccine.

          -  Known previous administration of a vaccine containing MPL, QS-21 and/or MF59.

          -  Planned administration of GSK's Herpes Zoster vaccine marketed as Shingrix or an
             adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su]
             within 180 days after the second dose of the study vaccine.

          -  Chronic administration (defined as more than 14 consecutive days in total) of
             immunosuppressants or other immune-modifying drugs during the period starting 6 months
             prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20
             mg/day, or equivalent). Inhaled and topical steroids are allowed.

          -  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 during the period starting
             3 months before the first dose of study vaccine or planned administration during the
             study period.

        Prior/Concurrent clinical study experience

        • Concurrently participating in another clinical study, at any time during the study
        period, in which the subject has been or will be exposed to an investigational or a
        non-investigational vaccine/product (pharmaceutical product or device).

        Other exclusions

          -  History of chronic alcohol consumption and/or drug abuse as deemed by the investigator
             to render the potential subject unable/unlikely to provide accurate safety reports.

          -  Body mass index greater than 40 kg/m^2.

          -  Planned move to a location that will prohibit participating in the trial until study
             end.

          -  Bedridden subjects.