NCT00569894

A Post Marking Study to Evaluate the Safety of FluMist in Children

A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29,296 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 24 Months – 59 Months
• Healthy volunteers: Accepted

Summary

To assess the safety of FluMist vaccination

Detailed description

* 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) \[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\]

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	FLuMist	One or two vaccinations with FluMist depending on prior vaccination status.
BIOLOGICAL	TIV (Injection)	One or two injections of TIV depending on previous status.
OTHER	Unvaccinated Control	no vaccine

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-12-10
• Last updated: 2012-03-08

Locations

1 site across 1 country: United States