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NCT00113880 · ClinicalTrials.gov registry record
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
A clinical trial of Healthy, sponsored by MedImmune.
- Completed
- Registry status
- 63,061
- Enrollment target
- 20
- Study locations
NCT00113880: Completed study of Healthy, sponsored by MedImmune.
NCT00113880 is a study of Healthy that has completed, run by MedImmune. The registered enrollment target is 63,061 participants, above the 589-participant average among 1,090 other Healthy trials with a reported enrollment target (10606% higher). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113880, a study of Healthy, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- 63,061 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.
Primary Outcome
An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.
Conditions Studied
Interventions
- BIOLOGICAL FluMist
Study Locations (20)
California
- Kaiser Permanente Pediatrics - Alameda
- Kaiser Permanente Pediatrics - Antioch
- Kaiser Permanente Pediatrics - Clovis
- Kaiser Permanente Pediatrics - Daly City
- Kaiser Permanente - Davis
- Kaiser Pediatric Injections - Fairfield
- Kaiser Permanente-Pediatrics - Folsom
- Kaiser Permanente Adult Injection - Fremont
- Kaiser Permanente Pediatrics - Fremont
- Kaiser Permanente Pediactrics - Fresno
- Kaiser Permanente Pediatrics - Gilroy
- Kaiser Pediatric Injection Station - Hayward
- Kaiser Permanente - Lincoln
- Kaiser Pediatric Injection Station - Livermore
- Kaiser Permanente Injection Clinic - Manteca
- Kaiser Permanente Pediatrics - Martinez
- Kaiser Permanente Adult Medicine - Milpitas
- Kaiser Permanente Employee Health - Milpitas
- Kaiser Permanente Pediatrics - Milpitas
- Kaiser Permanente Injection Clinic - Modesto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63,061 participants |
| Start Date | 2003-10 |
| Est. Completion | 2010-06 |
What the finished NCT00113880 record still lists
NCT00113880 is an observational study that tracks outcomes without assigning an intervention. Its 63,061 participants enrollment target places it among the larger protocols in the corpus, above the 589-participant average among 1,090 other Healthy trials with a reported enrollment target (10606% higher).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which FluMist is the first listed.
NCT00113880 names 20 study sites across 1 states, led by California.
Frequently Asked Questions
What is clinical trial NCT00113880 about?
NCT00113880 is a clinical study titled "A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults". The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.
What is the current status of trial NCT00113880?
This trial is currently completed. The enrollment target is 63,061 participants. The study started on 2003-10. Estimated completion is 2010-06.
What conditions does trial NCT00113880 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00113880?
The interventions under investigation include: FluMist (BIOLOGICAL).
Who is sponsoring clinical trial NCT00113880?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00113880 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00113880's enrollment target sits among peer trials
63,061 3rd of 1090 higher than 1,088 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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