Phase 4
Completed N=413
Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
Source: ClinicalTrials.gov NCT00233064 ↗Enrolled (actual)
413
Serious AEs
7.3%
Results posted
Oct 2008
Primary outcomePrimary: Number and Percentage of Participants With Immune Reactivity — 0; 1; 1; 0.0 Participants
Summary
The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants With Immune Reactivity |
0; 1; 1; 0.0; 0.5; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
- Written informed consent obtained from the patient's parent(s) or legal guardian(s)
- The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug
Exclusion Criteria
- Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
- Be receiving mechanical ventilation at the time of study entry (including CPAP)
- Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled).
- Mother with HIV infection (unless the child has been proven to be not infected)
- Life expectancy <6 months
- Known allergy to Ig products
- Acute respiratory or other acute infection or illness
- Previous reaction to IGIV, blood products, or other foreign proteins
- Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- Any previous receipt of MEDI-524
- Participation in other investigational drug product studies
Data sourced from ClinicalTrials.gov (NCT00233064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.