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NCT00686075 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,338
- Enrollment target
NCT00686075: Completed Phase 1 study, sponsored by MedImmune.
NCT00686075 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 1,338 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2130% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00686075, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,338 participants
- Enrollment target
Study Summary
Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (\<) 24 months of age and in infants 2 months of age.
Primary Outcome
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (\>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Interventions
- BIOLOGICAL MEDI-534, Cohort 1
- OTHER Placebo, Cohort 1
- BIOLOGICAL MEDI-534, Cohort 2
- OTHER Placebo, Cohort 2
- BIOLOGICAL MEDI-534, Cohort 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,338 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT00686075 record still lists
NCT00686075 is an interventional study that assigns participants to a tested intervention. Its 1,338 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2130% higher).
The record links to 0 conditions, and to 5 interventions - of which MEDI-534, Cohort 1 is the first listed.
NCT00686075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00686075 about?
NCT00686075 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants". Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (\<) 24 months of age and in infants 2 months of age.
What is the current status of trial NCT00686075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,338 participants. The study started on 2008-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00686075?
The interventions under investigation include: MEDI-534, Cohort 1 (BIOLOGICAL), Placebo, Cohort 1 (OTHER), MEDI-534, Cohort 2 (BIOLOGICAL), Placebo, Cohort 2 (OTHER), MEDI-534, Cohort 3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00686075?
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 NCT00686075's enrollment target sits among peer trials
1,338 4th of 2000 higher than 1,997 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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