Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the same Respiratory Syncytial Virus (RSV) Season

Study identifier:MI-CP127

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), and Palivizumab when Administered in the Same Season

Medical condition

Respiratory Syncytial Virus Infections, premature with gestational age <=35 weeks and <=6 months of age

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

260

Study type

Interventional

Age

N/A - 24 Months

Date

Study Start Date: 01 Apr 2006

Primary Completion Date: 01 Feb 2007

Study Completion Date: 01 Feb 2007

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2012 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
- The child must be in general good health at the time of study entry.
- The child’s parent(s)/legal guardian must provide written informed consent.
- The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
- Parent(s)/legal guardian of patient must have available telephone access.

Exclusion Criteria

- Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
- 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 (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
- Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
- Acute illness or progressive clinical disorder
- Active infection, including acute RSV infection, at the time of enrollment
- Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
- Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents
- Previous participation in a clinical trial of motavizumab
- Currently participating in any investigational study

No locations available

Arms	Assigned Interventions
Experimental: Motavizumab followed by Palivizumab 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological/Vaccine: Motavizumab, palivizumab Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
Experimental: Palivizumab followed by motavizumab 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological/Vaccine: Palivizumab, motavizumab Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.
Experimental: Motavizumab control 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)	Biological/Vaccine: Motavizumab Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Terramika Bellamy

301-398-0000

[email protected]

Contact Backup

Mark Eickhoff