A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)

Study Overview
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Brief Summary
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A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.

Detailed Description
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Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.

Official Title
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A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis), A Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children With a History of Prematurity

Conditions
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-Unhealthy Children With a History of Prematurity

Intervention / Treatment
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* Drug: MEDI-493


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday) The child's parent or legal guardian must provide written informed consent; and The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days) Parent/legal guardian of patient has available telephone access. Exclusion Criteria: Be hospitalized; Birth hospitalization > 6 weeks duration; Be receiving mechanical ventilation at the time of study entry (including CPAP); Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days; Congenital heart disease (CHD). (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled.) Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency; Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age hemoglobin <9.0 gm/dL white blood cell count <4,000 cells/mm3 platelet count <110,000 cells/mm3 Acute illness or progressive clinical disorder; History of recent difficult venous access; Active infection, including acute RSV infection; Previous reaction to IGIV, blood products, or other foreign proteins; Received within the past 120 days or currently receiving IGIV, other immunoglobulin products, or any investigational agents; Have ever received palivizumab; Currently participating in any investigational study; or Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MEDI-493|Active Comparator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum. |  | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events for 30 days after each injection of study drug. |  | Day 30 |