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 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

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.

Study Overview

• Status: Completed
• Conditions: -Unhealthy Children With a History of Prematurity
• Intervention / Treatment: Drug: MEDI-493

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Packard Children's Hospital at Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Genevieve Losonsky, M.D., "Unaffliliated"

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Study Completion (Actual): April 1, 2003

Study Registration Dates

• First Submitted: October 14, 2005
• First Submitted That Met QC Criteria: October 14, 2005
• First Posted (Estimate): October 18, 2005

Study Record Updates

• Last Update Posted (Estimate): November 15, 2010
• Last Update Submitted That Met QC Criteria: November 12, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Anti-Infective Agents; Antiviral Agents; Palivizumab
• Other Study ID Numbers: MI-CP097