Trial to Evaluate the Safety of Influenza Virus (FluMist) in Healthy Children and Healthy Adults

This study is ongoing, but not recruiting participants.

First Received: June 10, 2005 Last Updated: February 4, 2008 History of Changes

Sponsors and Collaborators:	MedImmune LLC Kaiser Permanente
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00113880

Purpose

This trial will assess the safety of FluMist vaccination, the rates of medically attended events (MAEs) 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.]

Condition	Intervention	Phase
Influenza	Biological: FluMist	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60000
Study Start Date:	October 2003
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season	Biological: FluMist Nasal Sprayer dose of FluMist with annual follow up
2 9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season	Biological: FluMist Nasal Sprayer dose of FluMist with annual follow up
3 18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.	Biological: FluMist Nasal Sprayer dose of FluMist with annual follow up

Eligibility

Ages Eligible for Study:	5 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

This is an observational study conducted over multiple years with multiple non-randomized control groups.

Criteria

Inclusion Criteria:

5-49 years of age
Members of the Kaiser Permanente Health Care Plan within Kaiser Permanente of Northern California and Permanente of Colorado

Exclusion Criteria:

Must not have any of the following: diabetes mellitus, asthma, or cardiovascular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113880

Show 78 Study Locations

Sponsors and Collaborators

MedImmune LLC

Kaiser Permanente

Investigators

Principal Investigator:	Roger Baxter, M.D.	Kaiser Permenente Vaccine Study Center (KPVSC)
Study Director:	Robert Walker, M.D.	MedImmune LLC

More Information

No publications provided

Responsible Party:	MedImmune Inc. ( Robert Walker, M.D. )
Study ID Numbers:	FM025
Study First Received:	June 10, 2005
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00113880 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Healthy

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on August 30, 2009