A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
Condition: Respiratory Syncytial Virus (RSV)
MeSH terms: Virus Diseases
Intervention: Placebo; RSV sF 20 mcg; MEDI7510 (20 mcg RSV sF); RSV sF 50 mcg; MEDI7510 (50 mcg RSV sF); RSV sF 80 mcg; MEDI7510 (80 mcg RSV sF)
Intervention description: Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.; Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.; Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 246.0
Sex: All
Minimum age: 60 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus (RSV); MEDI7510

Summary:

      The purpose of this study is to determine if the administration of single ascending
      intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in
      adults 60 years or older who are healthy or who have stable, chronic underlying medical
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 60 years

          -  Written informed consent and any locally required authorization obtained prior to any
             protocol related procedures

          -  Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or
             homebound

          -  Weight at or above 110 Pounds (lbs)

          -  Hemoglobin within normal range for age and gender

        Exclusion Criteria:

          -  History of allergy to any component of the vaccine

          -  Pregnancy or potential to become pregnant during the study. Females who have had a
             menstrual period within the 12 months prior to study enrollment or are undergoing any
             fertility treatment or who plan to undergo fertility treatments during the study
             period are excluded

          -  Any unstable 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. Participant with severe, untreated or uncontrolled underlying
             medical disease that might either compromise participant safety or affect the ability
             to assess safety of the investigational product are excluded

          -  Clinically significant abnormalities in Screening laboratory assessments or Screening
             electrocardiogram (ECG)

          -  History of hepatitis B or hepatitis C infection

          -  Cognitive disorder such that informed consent cannot be obtained directly from the
             participant

          -  Previous vaccination against respiratory syncytial virus (RSV)

          -  History of allergy to eggs in adulthood

          -  History of or current autoimmune disorder

          -  Immunosuppression caused by disease, including human immunodeficiency virus (HIV), or
             medications. Any oral prednisone dosing within 30 days of enrollment or planned dosing
             within the 360-day follow-up period would disqualify.

          -  History of splenectomy or of condition affecting splenic function

          -  History of cancer within preceding 5 years other than treated non-melanoma skin cancer

          -  Body Mass Index 40 or higher

          -  Significant infection or other acute illness, including fever over 100 fahrenheit (F)
             on the day prior to or day of randomization

          -  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

          -  History of thrombocytopenia or bleeding disorder or use of anticoagulants.
             Participants receiving drugs with anti-platelet activity such as nonsteroidal
             antiinflammatory drugs, clopidogrel or aspirin are not excluded

          -  Expected receipt of antipyretic or analgesic medication on a daily or every other day
             basis from randomization through 72 hours after receipt of investigational product
             (IP) [a daily dose of 163 milligram (mg) or higher is not considered a
             contraindication to enrollment]

          -  Participants who have significant scarring, tattoos, abrasions, cuts, or infections
             over the deltoid region of both arms that, in the principle investigator's (PI)
             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 PI's opinion
             would affect the participants 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.