A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

Exclusion Criteria

• 1) Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
• 2) Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of investigational product
• 3) Cohort 1 only: weight < the fifth percentile for age on the day of randomization
• 4) Cohort 2 only: history of low birth-weight (ie, < 2,500 grams at birth) or weight < fifth percentile for age on the day of randomization
• 5) 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 investigational product dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
• 6) Any current or expected receipt of immunosuppressive agents including steroids (≥ 2 mg/kg per day of prednisone or its equivalent, or ≥ 20 mg/day if the participant weighs >10 kg, given daily or on alternate days for ≥ 14 days); children in this category should not receive investigational product until immunosuppressive agents including corticosteroid therapy have been discontinued for ≥ 30 days; the use of topical steroids is permitted according to the judgment of the investigator
• 7) History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing
• 8) History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing
• 9) Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product dosing
• 10) 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 dose
• 11) Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any dose
• 12) Known or suspected immunodeficiency, including human immunodeficiency virus
• 13) Living in the same home or enrolled in the same classroom at day care with infants < 24 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
• 14) Contact with pregnant caregiver within 28 days after each dose
• 15) Household contact with an immunocompromised person within 28 days after each dose; the participant should also avoid close contact with immunocompromised individuals for at least 28 days after each investigational product dose
• 16) Household contact within 28 days after each dose with a healthcare worker who has direct patient care responsibilities or household contact within 28 days after each dose with someone who is a day care provider or preschool teacher for children < 24 months of age
• 17) History of allergic reaction to any component of the investigational product
• 18) Previous medical history or evidence of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the participant
• 19) Known or suspected active or chronic hepatitis infection
• 20) History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia), chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
• 21) A family member or a household contact who is an employee of the research center or otherwise involved with the conduct of the study
• 22) Any condition that, in the opinion of the investigator, might interfere with investigational product evaluation