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NCT00233064 · ClinicalTrials.gov registry record · Phase 4

Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

A Phase 4 study of Chronic Lung Disease, sponsored by MedImmune.

Completed
Registry status
Phase 4
Development phase
417
Enrollment target
20
Study locations

NCT00233064 is a Phase 4 study of Chronic Lung Disease that has completed, run by MedImmune. The registered enrollment target is 417 participants, above the 311-participant average among 9 other Chronic Lung Disease trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT00233064, a Phase 4 study of Chronic Lung Disease, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 4
Development phase
417 participants
Enrollment target
20
Study locations

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

Chronic Lung Disease

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

FieldValue
Enrollment Target 417 participants
Start Date 2005-10
Est. Completion 2007-11
Phase Phase 4

Sponsor

MedImmune

210 total trials

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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, categorized as Phase 4. The registered enrollment target is 417 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 311-participant average among 9 other Chronic Lung Disease trials with a reported enrollment target (34% higher). The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.

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.

NCT00233064 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Alabama, Massachusetts.

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.

What interventions are being tested in trial NCT00233064?

The interventions under investigation include: Lyophilized Palivizumab (BIOLOGICAL), Liquid Palivizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00233064?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.