Study to Evaluate MEDI-534 in Healthy Adults

Exclusion Criteria

• •Acute illness on the day of randomization
• •Fever (greater than or equal to 99.5°F oral or greater than or equal to 100.1°F tympanic) and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
• •Any drug therapy (chronic or other) within 7 days prior to randomization (except for certain medications such as contraceptives, topical \[i.e., dermatologic\] corticosteroids, or infrequent use of over-the-counter pain relievers, following approval from the sponsor) or expected receipt through 28 days after study vaccine dosing
• •Receipt of immunoglobulin or blood products within 90 days prior to screening or expected receipt through 28 days after study vaccine dosing
• •Receipt of any investigational drug within 60 days prior to randomization or expected receipt during the study period (i.e., through 180 days after study vaccine dosing)
• •Receipt of an approved vaccine within 30 days prior to randomization or expected receipt through 28 days after study vaccine dosing
• •History of immunodeficiency or receipt of immunosuppressive agents, or expected receipt of an immunosuppressive agent through 28 days after study vaccine dosing
• •Close contact at home or in the workplace with children under 2 years of age
• •Household contact who is immunocompromised; volunteer should also avoid close contact with immunocompromised individuals for at least 21 days after vaccination
• •History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc.)
• •Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the volunteer
• •Any evidence of end organ dysfunction
• •Current, or history of, clinically significant abnormality on electrocardiogram (ECG) (screening ECG must be within 30 days prior to randomization)
• •Evidence of active infection with HIV or hepatitis A, B, or C virus, or serologic evidence of past infection with hepatitis B or C virus
• •At screening (must be within 7 days prior to randomization), any of the following laboratory tests outside of the laboratory normal range: CBC: hemoglobin (Hgb), WBC count, platelet count; AST, ALT, BUN, creatinine; or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, may potentially confound analysis of study results
• •Nursing mother
• •History of alcohol or drug abuse in the past 2 years
• •History of medical diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
• •History of any smoking in the past 5 years
• •Previous vaccination against Respiratory Syncytial Virus (RSV) or Parainfluenza Virus Type 3 (PIV3) in a clinical trial
• •Employees of the research center, any individuals involved with the conduct of the study, or family members of such individuals
• •Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation