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NCT00946101 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
A Phase 4 study of Influenza, sponsored by MedImmune.
- Completed
- Registry status
- Phase 4
- Development phase
- 326
- Enrollment target
- 16
- Study locations
NCT00946101: Completed Phase 4 study of Influenza, sponsored by MedImmune.
NCT00946101 is a Phase 4 study of Influenza that has completed, run by MedImmune. The registered enrollment target is 326 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00946101, a Phase 4 study of Influenza, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 326 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children.
Primary Outcome
The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
Study Locations (16)
California
- Benchmark Research - Sacramento
- California Research Foundation - San Diego
- Benchmark Research - San Francisco
Texas
- Benchmark Research - Austin
- Benchmark Research Ft. Worth - Fort Worth
- Benchmark Research San Angelo - San Angelo
Kentucky
- Kentucky Pediatric Research Center - Bardstown
- Central Kentucky Research Associates, Inc. - Lexington
Alabama
- Coastal Clinic Research, Inc. - Mobile
Missouri
- Sundance Clinical Research - St Louis
Nebraska
- Meridian Clinical Research - Omaha
Nevada
- Clinical Research Center of Nevada - Henderson
New York
- Rochester Clinical Research Inc. - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00946101 record still lists
NCT00946101 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00946101 lists 16 locations in 11 states (California, Texas, Kentucky).
Frequently Asked Questions
What is clinical trial NCT00946101 about?
NCT00946101 is a clinical study titled "A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age". The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children.
What is the current status of trial NCT00946101?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 326 participants. The study started on 2009-08. Estimated completion is 2010-03.
What conditions does trial NCT00946101 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00946101?
The interventions under investigation include: Placebo (BIOLOGICAL), MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] (BIOLOGICAL).
Who is sponsoring clinical trial NCT00946101?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00946101 being conducted?
This trial has 16 study locations across Alabama, California, Kentucky, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
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 NCT00946101's enrollment target sits among peer trials
326 61st of 156 higher than 96 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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