A Post Marking Study to Evaluate the Safety of FluMist in Children - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00569894

Purpose

To assess the safety of FluMist vaccination

Condition	Intervention	Phase
Healthy	Biological: FLuMist Biological: TIV (Injection) Other: Unvaccinated Control	Phase IV

Drug Information available for: Influenza Vaccines Fluvirin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

(Planned Analyses)-Medically Attended Events(MAEs)of anaphylaxis(see Appendix A) and urticaria,asthma and wheezing,grouped diagnosis,wild-type influenza, MAEs similar to SAEs, Em. Dept. setting, hospitalization setting, MAEs for death,Rare MA [ Time Frame: 1, 3, 21, or 42 days post dose; 6 months post dose; entire study period) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25000
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator TIV	Biological: TIV (Injection) One or two injections of TIV depending on previous status.
1: Active Comparator FluMist	Biological: FLuMist One or two vaccinations with FluMist depending on prior vaccination status.
3: No Intervention Unvaccinated	Other: Unvaccinated Control no vaccine

Detailed Description:

To assess the safety of FluMist vaccination Rates of medically attended events (MAEs; as defined in Section 4.1) in FluMist recipients, including serious adverse events (SAEs), anaphylaxis (see Appendix A), urticaria, asthma, wheezing, pre-specified grouped diagnoses (see Appendix B), and rare events potentially related to wild-type influenza (see Appendix C), 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.

Eligibility

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569894

Locations

United States, California
Kaiser Permanente Vaccine Study Center
Oakland, California, United States, 94612

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Holli Hamilton, M.D.

MedImmune LLC

More Information

Responsible Party:	MedImmune ( Holli Hamilton, M.D. )
Study ID Numbers:	MI-MA-162
Study First Received:	December 6, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00569894
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 15, 2009