A Post Marking Study to Evaluate the Safety of FluMist in Children
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|ClinicalTrials.gov Identifier: NCT00569894|
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : March 8, 2012
|Condition or disease||Intervention/treatment|
|Healthy||Biological: FLuMist Biological: TIV (Injection) Other: Unvaccinated Control|
- To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.
- To assess the safety of annual FluMist re-vaccination [Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.]
- To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) [Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.]
|Study Type :||Observational|
|Actual Enrollment :||29296 participants|
|Official Title:||A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Biological: TIV (Injection)
One or two injections of TIV depending on previous status.
One or two vaccinations with FluMist depending on prior vaccination status.
Other: Unvaccinated Control
- Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting. [ Time Frame: 1, 3, 21, or 42 days post dose; 6 months post dose; entire study period) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569894
|United States, California|
|Oakland, California, United States|
|Study Director:||Seth Toback, M.D.||MedImmune LLC|