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A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults

NCT ID: NCT00113880

Last Updated: 2013-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63061 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.

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Detailed Description

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The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events \[SAEs\], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season

FluMist

Intervention Type BIOLOGICAL

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

FluMist

Intervention Type BIOLOGICAL

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.

FluMist

Intervention Type BIOLOGICAL

Nasal Sprayer dose of FluMist with annual follow up

Interventions

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FluMist

Nasal Sprayer dose of FluMist with annual follow up

Intervention Type BIOLOGICAL

FluMist

Nasal Sprayer dose of FluMist with annual follow up

Intervention Type BIOLOGICAL

FluMist

Nasal Sprayer dose of FluMist with annual follow up

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 5-49 years of age
* Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii

Exclusion Criteria

* Must not have had any high risk underlying medical conditions, includig asthma
Minimum Eligible Age

5 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Ambrose, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Kaiser Permanente Pediatrics

Alameda, California, United States

Site Status

Kaiser Permanente Pediatrics

Antioch, California, United States

Site Status

Kaiser Permanente Pediatrics

Clovis, California, United States

Site Status

Kaiser Permanente Pediatrics

Daly City, California, United States

Site Status

Kaiser Permanente

Davis, California, United States

Site Status

Kaiser Pediatric Injections

Fairfield, California, United States

Site Status

Kaiser Permanente-Pediatrics

Folsom, California, United States

Site Status

Kaiser Permanente Adult Injection

Fremont, California, United States

Site Status

Kaiser Permanente Pediatrics

Fremont, California, United States

Site Status

Kaiser Permanente Pediactrics

Fresno, California, United States

Site Status

Kaiser Permanente Pediatrics

Gilroy, California, United States

Site Status

Kaiser Pediatric Injection Station

Hayward, California, United States

Site Status

Kaiser Permanente

Lincoln, California, United States

Site Status

Kaiser Pediatric Injection Station

Livermore, California, United States

Site Status

Kaiser Permanente Injection Clinic

Manteca, California, United States

Site Status

Kaiser Permanente Pediatrics

Martinez, California, United States

Site Status

Kaiser Permanente Adult Medicine

Milpitas, California, United States

Site Status

Kaiser Permanente Employee Health

Milpitas, California, United States

Site Status

Kaiser Permanente Pediatrics

Milpitas, California, United States

Site Status

Kaiser Permanente Injection Clinic

Modesto, California, United States

Site Status

Kaiser Permanente Medicine Dept.

Modesto, California, United States

Site Status

Kaiser Permanente Pediatrics

Mountain View, California, United States

Site Status

Kaiser Permanente Pediatrics

Napa, California, United States

Site Status

Kaiser Permanente Pediatrics

Novato, California, United States

Site Status

Kaiser Permanente Employee Health

Oakland, California, United States

Site Status

Kaiser Permanente Injection Clinic

Oakland, California, United States

Site Status

Kaiser Permanente Pediatrics

Oakland, California, United States

Site Status

Kaiser Permanente Regional Employee Health

Oakland, California, United States

Site Status

Kaiser Permanente Pediatrics

Petaluma, California, United States

Site Status

Kaiser Permanente Pediatrics

Pleasanton, California, United States

Site Status

Kaiser Permanente Pediatrics

Rancho Cordova, California, United States

Site Status

Kaiser Permanente

Redwood City, California, United States

Site Status

Kaiser Permanente Adult Injection Clinic

Richmond, California, United States

Site Status

Kaiser Permanente Pediatrics

Richmond, California, United States

Site Status

Kaiser Permanente Pediatrics

Roseville, California, United States

Site Status

Kaiser Permanente

Roseville, California, United States

Site Status

Kaiser Permanente, Point West Clinic Pediatric Injection

Sacramento, California, United States

Site Status

Kaiser Permanente

Sacramento, California, United States

Site Status

Kaiser Pediatric Injection Station

Sacramento, California, United States

Site Status

Kaiser Permanente Medicine Dept.

Sacramento, California, United States

Site Status

Kaiser Permanente Medicine Dept.

San Francisco, California, United States

Site Status

Kaiser Permanente Pediatrics

San Francisco, California, United States

Site Status

Kaiser Permanente Pharmacy

San Francisco, California, United States

Site Status

Kaiser Pediatric Adult Medicine

San Jose, California, United States

Site Status

Kaiser Pediatric Injection Clinic

San Jose, California, United States

Site Status

Kaiser Permanente Employee Health

San Rafael, California, United States

Site Status

Kaiser Permanente Pediatrics

San Rafael, California, United States

Site Status

Kaiser Permanente Adult Medicine

Santa Clara, California, United States

Site Status

Kaiser Permanente Employee Health

Santa Rosa, California, United States

Site Status

Kaiser Permanente Pediatrics

Santa Rosa, California, United States

Site Status

Kaiser Permanente Pediatrics

Selma, California, United States

Site Status

Kaiser Permanente Injection/Allergy

Stockton, California, United States

Site Status

Kaiser Permanente Pediatrics

Tracy, California, United States

Site Status

Kaiser Pediatric Injection Room

Vacaville, California, United States

Site Status

Kaiser Permanente Adult Medicine

Vacaville, California, United States

Site Status

Kaiser Permanente Injection Clinic

Vallejo, California, United States

Site Status

Kaiser Permanente Pediatric Injections

Vallejo, California, United States

Site Status

Kaiser Permanente Pediatrics

Walnut Creek, California, United States

Site Status

Kaiser Permanente Pediatrics

Walnut Creek, California, United States

Site Status

Kaiser Permanente, Hidden Lake

Arvada, Colorado, United States

Site Status

Kaiser Permanente, Aurora Centrepoint

Aurora, Colorado, United States

Site Status

Kaiser Permanente, Smoky Hill

Aurora, Colorado, United States

Site Status

Kaiser Permanente, Baseline

Boulder, Colorado, United States

Site Status

Kaiser Permanente, Boulder

Boulder, Colorado, United States

Site Status

Kaiser Permanente, Broomfield

Broomfield, Colorado, United States

Site Status

Kaiser Permanente, Skyline

Denver, Colorado, United States

Site Status

Kaiser Permanente, East

Denver, Colorado, United States

Site Status

Kaiser Permanente, Englewood

Englewood, Colorado, United States

Site Status

Kaiser Permanente

Highlands Ranch, Colorado, United States

Site Status

Kaiser Permanente

Lafayette, Colorado, United States

Site Status

Kaiser Permanente, Lakewood

Lakewood, Colorado, United States

Site Status

Kaiser Permanente Arapahoe

Littleton, Colorado, United States

Site Status

Kaiser Permanente, Southwest

Littleton, Colorado, United States

Site Status

Kaiser Permanente, Ken Caryl

Littleton, Colorado, United States

Site Status

Kaiser Permanente, Longmont Primary Care

Longmont, Colorado, United States

Site Status

Kaiser Permanente, Westminster

Westminster, Colorado, United States

Site Status

Kaiser Permanente, Wheatridge

Wheat Ridge, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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FM025

Identifier Type: -

Identifier Source: org_study_id

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