At a glance
ClinicalIndex Comparison RecordN/ACompleted· 63,061 enrolled
Drug / intervention
FluMist +2 morebiological
Likely dose
FluMist nasal spray vaccine, annual doseAI-extracted
Key inclusion· 2
- ✓Age 5-49 years
- ✓Member of Kaiser Permanente Health Care Plan in Northern California, Colorado, or Hawaii
Key exclusion· 1
- ✕High-risk underlying medical conditions including asthma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age
In Brief
An observational study evaluating FluMist for Healthy. Completed, enrolled 63,061 participants across 77 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
First PostedJun 2005
Primary CompletionSep 2008
Study CompletionJun 2010
TodayJul 2026
First PostedJun 13, 2005
Enrollment StartOct 1, 2003
Primary CompletionSep 1, 2008
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.1 years ago
Interventions
FluMistbiological
Nasal Sprayer dose of FluMist with annual follow up
FluMistbiological
Nasal Sprayer dose of FluMist with annual follow up
FluMistbiological
Nasal Sprayer dose of FluMist with annual follow up