Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

This study is designed to describe the safety, tolerability, immunogenicity, and pharmacokinetics of escalating, repeated IM injections (the intended route of administration for immunoprophylaxis) of MEDI-524, initially in children £6 months old with a history of prematurity (³32 to £35 weeks gestation, without BPD), one of the target populations of infants at high risk for serious RSV disease.

Inclusion criteria

• All male or female children must have met all the following criteria:
• [Groups 1, 2, and 3] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-month birthday) or [Group 3 only] The child must have been £24 months of age at the time of entry into the study (child must have been entered on or before their 24-month birthday) and diagnosed with BPD, with stable or decreasing doses of diuretics, steroids, or bronchodilators within the previous 6 months
• The child must have been in general good health at the time of entry
• The child's parent or legal guardian must have provided written informed consent; and
• The child must have been able to complete the follow-up visits through 90 days following last injection of MEDI-524
• Parent/legal guardian of patient must have had available telephone access

Exclusion criteria

• Children must have had none of the following:
• Hospitalization at the time of study entry (unless discharge was expected within 3 days after entry into the study)
• [All children in Groups 1 and 2; only children £6 months of age in Group 3] Birth hospitalization >6 weeks duration or [Only children >6 months of age in Group 3] Birth hospitalization >12 weeks duration
• Been receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including CPAP)
• [Groups 1 and 2 only] Diagnosis of 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)
• Evidence of infection with hepatitis A, B, or C virus
• Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
• Mother with known HIV infection
• 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 <9.5 gm/dL; white blood cell count <4,000 cells/mm3; platelet count <120,000 cells/mm3
• Acute illness or progressive clinical disorder
• Active infection, including acute RSV infection
• Previous reaction to IGIV, blood products, or other foreign proteins
• Have ever received palivizumab
• Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGamÒ], IVIG), or any investigational agents
• Currently participating in any investigational study
• Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.