A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
Condition: Respiratory Syncytial Virus
Intervention: MEDI7510; IIV; Placebo
Intervention description: RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant; Marketed Inactivated Influenza Vaccine; Sterile Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1900.0
Sex: All
Minimum age: 60 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: RSV; Older adults; MEDI7510; Vaccine; Efficacy

Summary:

      This study will be the first assessment of the efficacy of MEDI7510 for the prevention of
      respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy
      and of endpoint incidence in the placebo arm. It will also assess the safety and
      immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in
      the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed
      with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and
      Season 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 60 years at the time of screening.

          -  Medically stable such that, according to the judgment of the investigator,
             hospitalization within the study period is not anticipated and the subject appears
             likely to be able to remain in follow-up through the end of protocol-specified
             follow-up.

          -  (Season 2): Subject received MEDI7510 and IIV in the Northern Hemisphere in Season 1.

        Exclusion Criteria:

          -  History of allergy to any component of the vaccine.

          -  Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.

          -  History of allergy to or intolerance of IIV.

          -  Pregnancy or potential to become pregnant during the study. Females who (1) have had a
             menstrual period within the 12 months prior to study enrollment or (2) are undergoing
             any fertility treatment or who plan to undergo fertility treatments during the study
             period are excluded.

          -  History of Guillain-Barré syndrome.

          -  Previous vaccination against RSV.

          -  History of allergy to eggs in adulthood.

          -  History of or current autoimmune disorder, with the exception of stable, treated
             hypothyroidism caused by autoimmune thyroiditis, which is acceptable.

          -  Immunosuppression caused by disease, including human immunodeficiency virus infection
             (assessed by history), or medications. Any receipt of oral or intravenous
             glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the
             follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular
             corticosteroids do not disqualify. Expected need for immunosuppressive medications
             during the follow-up period would disqualify.

          -  History of cancer within preceding 5 years other than treated non-melanoma skin
             cancer, locally-treated cervical cancer or in situ carcinoma of the breast.

          -  Receipt of any non-study vaccine within 28 days prior to study dosing or expected
             receipt of non-study vaccine prior to the Day 29 visit in Season 1.

          -  Receipt of any investigational product (IP) in the 90 days prior to randomization or
             expected receipt of IP during the period of study follow-up.

          -  Receipt of immunoglobulins or blood products within 4 months of study dosing (120
             days) or expected receipt of immunoglobulins or blood products during the period of
             study follow-up.

          -  Current bleeding or clotting disorder including use of anticoagulants other than drugs
             with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs,
             clopidogrel, ticagrelor or aspirin).

          -  History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the
             investigator, would affect the subject's safety or compliance with study.

          -  (Season 2): Related Grade 3 or 4 adverse event (AE) including Grade 3 or 4 local
             reaction to either MEDI7510 or IIV, any adverse event of special interest (AESI) for
             an adjuvanted vaccine, or any related serious adverse event (SAE).