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

Completed

• Conditions: Healthy
• Interventions: Biological: TIV (Injection); Biological: FLuMist; Other: Unvaccinated Control

• Registration Number: NCT00569894
• Lead Sponsor: MedImmune LLC

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29296

Inclusion Criteria

• Healthy
• Age: born within the same calendar quarter as the reference FluMist vaccinee.

Exclusion Criteria

• Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	TIV (Injection)	TIV
1	FLuMist	FluMist
3	Unvaccinated Control	Unvaccinated

Primary Outcome Measures

Name	Time	Method
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.	1, 3, 21, or 42 days post dose; 6 months post dose; entire study period)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oakland, California, United States