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NCT00767416 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT00767416: Completed Phase 1 study, sponsored by MedImmune.
NCT00767416 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00767416, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 to \<24 months of age.
Primary Outcome
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Interventions
- OTHER Placebo
- BIOLOGICAL MEDI-559
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT00767416 record still lists
NCT00767416 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00767416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00767416 about?
NCT00767416 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children". The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 to \<24 months of age.
What is the current status of trial NCT00767416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2008-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00767416?
The interventions under investigation include: Placebo (OTHER), MEDI-559 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00767416?
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 NCT00767416's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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