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)

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.