Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age

Exclusion Criteria

• •Any fever (equal to or greater than 100.4°F \[equal to or greater than 38.0°C\], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization
• •Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
• •Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
• •Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs \>10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator
• •History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing
• •History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing
• •Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing
• •Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
• •Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
• •Known or suspected immunodeficiency, including HIV
• •Living in the same home or enrolled in the same classroom at day care with infants \<24 months of age (only one child per household may be enrolled into the study)
• •Contact with pregnant caregiver
• •A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose
• •A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months
• •History of allergic reaction to any component of the study vaccine
• •Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
• •Known or suspected active or chronic hepatitis infection
• •History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
• •Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
• •Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation