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: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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:

Assess the Rates of Medically Attended Events(MAEs)of anaphylaxis; (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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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)

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

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.]

Eligibility

Ages Eligible for Study:	24 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

The populations to be assessed are FluMist recipients, TIV recipient controls, and unvaccinated controls.

Members of the Kaiser Permanente Health Care Plan may be included in this study as part of routine care at their participating health centers within the Kaiser Permanente health maintenance organization (HMO) of Northern California.

Criteria

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.

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

No publications provided

Responsible Party:	MedImmune ( Holli Hamilton, M.D. )
Study ID Numbers:	MI-MA-162
Study First Received:	December 6, 2007
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00569894 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 06, 2009