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)

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Palivizumab

Criteria

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.