Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
Condition: Respiratory Viral Infections; Respiratory Syncytial Virus Infections; Parainfluenza Virus 3, Human
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Paramyxoviridae Infections
Intervention: MEDI-534; MEDI-534; MEDI-534
Intervention description: Multiple doses of MEDI-534 or Placebo at 10^4 TCID50; Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.; Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lower Respiratory Tract Illness; RSV and PIV3 infection

Summary:

      The overall objective of the MEDI-534 clinical development program is to evaluate the safety,
      efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in
      young infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female whose age on the day of randomization is 6 to <24 months (reached 6th
             month birthday and not yet reached 2nd year birthday)

          -  Subject is seronegative to both RSV and PIV3 at screening

          -  Subject was the product of normal full term pregnancy (defined as >36 weeks gestation)

          -  Subject is in general good health

          -  Subject's legal representative is available by telephone

          -  Written informed consent and HIPAA authorization (if applicable) obtained from the
             subject's legal representative

          -  Subject's legal representative is able to understand and comply with the requirements
             of the protocol as judged by the investigator

          -  Subject is available to complete the follow-up period, which will be through the end
             of RSV season (provisionally defined as 01/Apr for the United States) or 180 days
             after the final dose of study vaccine, whichever is later

          -  Subject's legal representative must be willing and able to bring the subject to the
             study site for evaluation of respiratory illness in accordance with the protocol

        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