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NCT00129766 · ClinicalTrials.gov registry record · Phase 3
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
A Phase 3 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,635
- Enrollment target
NCT00129766: Completed Phase 3 study, sponsored by MedImmune.
NCT00129766 is a Phase 3 study that has completed, run by MedImmune. The registered enrollment target is 6,635 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (759% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00129766, a Phase 3 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,635 participants
- Enrollment target
Study Summary
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.
Primary Outcome
RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).
Interventions
- BIOLOGICAL palivizumab
- BIOLOGICAL motavizumab (MEDI-524)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,635 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-05 |
| Phase | Phase 3 |
What the finished NCT00129766 record still lists
NCT00129766 is an interventional study that assigns participants to a tested intervention. Its 6,635 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (759% higher).
The record links to 0 conditions, and to 2 interventions - of which palivizumab is the first listed.
NCT00129766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00129766 about?
NCT00129766 is a clinical study titled "Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children". The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was ...
What is the current status of trial NCT00129766?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,635 participants. The study started on 2004-11. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00129766?
The interventions under investigation include: palivizumab (BIOLOGICAL), motavizumab (MEDI-524) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00129766?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00129766's enrollment target sits among peer trials
6,635 35th of 2000 higher than 1,966 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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