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NCT00121108 · ClinicalTrials.gov registry record · Phase 3
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
A Phase 3 study of Healthy, sponsored by MedImmune.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,127
- Enrollment target
- 12
- Study locations
NCT00121108: Completed Phase 3 study of Healthy, sponsored by MedImmune.
NCT00121108 is a Phase 3 study of Healthy that has completed, run by MedImmune. The registered enrollment target is 2,127 participants, above the 645-participant average among 1,090 other Healthy trials with a reported enrollment target (230% higher). The trial reports 12 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00121108, a Phase 3 study of Healthy, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,127 participants
- Enrollment target
- 12
- Study locations
Study Summary
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.
Primary Outcome
An RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive central real-time reverse transcription polymerase chain reaction (RT-PCR) RSV test collected within 3 days of hospitalization or 2) new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Motavizumab
Study Locations (12)
Arizona
- Research Site - Chinle
- Research Site - Cibecue
- Research Site - Fort Definace
- Research Site - San Carlos
- Research Site - Tuba City
- Research Site - Whiteriver
- Research Site - Winslow
New Mexico
- Research Site - Bloomfield
- Research Site - Crownpoint
- Research Site - Gallup
- Research Site - Shiprock
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,127 participants |
| Start Date | 2004-11-15 |
| Est. Completion | 2010-12-27 |
| Phase | Phase 3 |
What the finished NCT00121108 record still lists
NCT00121108 is an interventional study that assigns participants to a tested intervention. Its 2,127 participants enrollment target places it among the larger protocols in the corpus, above the 645-participant average among 1,090 other Healthy trials with a reported enrollment target (230% higher).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00121108 lists 12 locations in 3 states (Arizona, New Mexico, Maryland).
Frequently Asked Questions
What is clinical trial NCT00121108 about?
NCT00121108 is a clinical study titled "MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States". MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.
What is the current status of trial NCT00121108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,127 participants. The study started on 2004-11-15. Estimated completion is 2010-12-27.
What conditions does trial NCT00121108 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00121108?
The interventions under investigation include: Placebo (OTHER), Motavizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00121108?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00121108 being conducted?
This trial has 12 study locations across Arizona, Maryland, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00121108's enrollment target sits among peer trials
2,127 22nd of 1090 higher than 1,069 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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