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Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
NCT00233064 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Lyophilized Palivizumab
- BIOLOGICAL Liquid Palivizumab
Study Locations (20)
California
- Family Medical Center — Foothill Ranch
- Edinger Medical Group — Fountain Valley
- Doctors Medical Group — West Covina
- Convenience Care — West Covina
Alabama
- Birmingham Pediatric Associates — Birmingham
- Clinical Research Consultants — Hoover
- The University of Alabama School of Medicine — Tuscaloosa
Massachusetts
- Boston University Medical Center — Boston
- Pediatric Association of Fall River — Fall River
- Woburn Pediatric Associates — Woburn
Kentucky
- Physicians to Children and Adolescents — Bardstown
- Peak Medical Research LLC — Owensboro
Arkansas
- All for Kids Pediatric Clinic — Little Rock
Connecticut
- Norwich Pediatric Group, P.C. — Norwich
Georgia
- The Allergy Center at Brookstone — Columbus
Michigan
- Michigan Institute of Medicine — Livonia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00233064
The ClinicalTrials.gov registry entry for NCT00233064 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 417 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Lung Disease appearing as the primary indexed condition, and to 2 interventions — of which Lyophilized Palivizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00233064 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Alabama, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00233064 about?
NCT00233064 is a clinical study titled "Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)". 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-paliviz...
What is the current status of trial NCT00233064?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 417 participants. The study started on 2005-10. Estimated completion is 2007-11.
What conditions does trial NCT00233064 study?
This clinical trial studies the following conditions: Chronic Lung Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00233064?
The interventions under investigation include: Lyophilized Palivizumab (BIOLOGICAL), Liquid Palivizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00233064?
This trial is sponsored by MedImmune, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00233064 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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