A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
Condition: Respiratory Syncytial Virus (RSV)
Intervention: MEDI7510; IIV
Intervention description: RSV sF antigen plus adjuvant; Marketed Inactivated Influenza Vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 60 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: RSV; Older adults; MEDI7510; Vaccine

Summary:

      The goal of this study is to evaluate the safety, tolerability and immunogenicity of
      ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60
      years or older who are healthy or who have stable, chronic underlying medical conditions.
      This study will also provide preliminary safety and immunogenicity data to support concurrent
      dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a
      dose previously assessed in the Phase 1a study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 60 years

          -  Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or
             homebound)

          -  Weight greater than 90 lbs

          -  Hemoglobin greater than or equal to 10.5 g/dL for women and greater than or equal to
             11 g/dL for men

          -  Subject able to complete follow-up period of 360 days after dosing

        Exclusion Criteria:

          -  History of allergy to: any component of the vaccine; IIV or intolerance of IIV; eggs
             in adulthood

          -  Receipt of seasonal flu shot within 60 days prior to dosing

          -  Any unstable acute or chronic medical condition, including one that has resulted in
             change in therapy (medication or other) in the 30 days prior to randomization or
             hospitalization in the previous year or might be predicted to result in
             hospitalization in the year after enrollment. Subjects with severe, untreated or
             uncontrolled underlying medical disease that might either compromise subject safety or
             affect the ability to assess safety of the investigational product are excluded.
             Medications taken on an as-needed basis are permitted to start or stop during the 30
             days prior to randomization unless they are medications not previously taken by the
             subject

          -  Clinically significant abnormalities in screening laboratory assessments or screening
             ECG

          -  History of hepatitis B or hepatitis C infection

          -  History of Guillain-Barré syndrome

          -  Cognitive disorder such that informed consent cannot be obtained directly from the
             subject

          -  Previous vaccination against RSV

          -  History of or current autoimmune disorder

          -  Immunosuppression caused by disease, including human immunodeficiency virus (HIV)
             infection, or medications. Any oral prednisone dosing within 30 days of enrollment or
             planned dosing within the 360-day follow-up period would disqualify. Expected need for
             immunosuppressive medications during the 360-day follow-up period would disqualify

          -  History of splenectomy or of condition affecting splenic function (eg,
             hemoglobinopathy)

          -  History of cancer within preceding 5 years other than treated non-melanoma skin cancer

          -  Body Mass Index 40 or higher

          -  Receipt of any nonstudy vaccine within 30 days prior to study dosing or expected
             receipt of nonstudy vaccine within 30 days after study dosing

          -  Receipt of any investigational product in the 90 days prior to randomization or
             expected receipt of investigational product 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 investigational product 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)

          -  Expected receipt of antipyretic or analgesic medication on a daily or every other day
             basis from randomization through 72 hours after receipt of IP (Note: A daily dose of
             aspirin is not considered a contraindication to enrollment.)

          -  Subjects who have significant scarring, tattoos, abrasions, cuts, or infections over
             the deltoid region of both arms that, in the investigators opinion, could interfere
             with evaluation of injection site local reactions

          -  Concurrent enrollment in another clinical study that involves any invasive clinical
             procedure, including phlebotomy

          -  History of alcohol or drug abuse or psychiatric disorder that, in the investigators
             opinion, would affect the subject's safety or compliance with study

          -  Employees of individuals directly involved with the conduct of the study, individuals
             who themselves are involved with the conduct of the study, or immediate family members
             of such individuals