NCT00113880

A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults

Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63,061 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 5 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	FluMist	Nasal Sprayer dose of FluMist with annual follow up
BIOLOGICAL	FluMist	Nasal Sprayer dose of FluMist with annual follow up
BIOLOGICAL	FluMist	Nasal Sprayer dose of FluMist with annual follow up

Timeline

• Start date: 2003-10-01
• Primary completion: 2008-09-01
• Completion: 2010-06-01
• First posted: 2005-06-13
• Last updated: 2013-01-08
• Results posted: 2013-01-08

Locations

77 sites across 1 country: United States