Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age
Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age
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.
The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.
Inclusion Criteria:
Exclusion Criteria: