Clinical trial NCT00113880: A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-06-13
Enrollment: 63061
Sex: ALL
Minimum age (years): 5
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an observational study conducted over multiple years with multiple non-randomized control groups.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
timeFrame: 21 and 42 days
measure: Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
timeFrame: 21 and 42 days
measure: Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
timeFrame: 3 days
measure: Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.
timeFrame: 21 and 42 days
measure: Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups
timeFrame: 21 and 42 days
measure: Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group
timeFrame: 21 and 42 days
measure: Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group
timeFrame: 180 days
measure: Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group
timeFrame: 180 days
measure: Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups
timeFrame: 21 and 42 days
measure: Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group
timeFrame: 21 and 42 days
measure: Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls
timeFrame: 21 and 42 days
measure: Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls
timeFrame: 180 days
measure: Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls
timeFrame: 180 days
Secondary outcomes:
measure: Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls
timeFrame: 21 days
measure: Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
timeFrame: 42 days
measure: Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days
timeFrame: 42 days
measure: Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
timeFrame: 180 days
measure: Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls
timeFrame: 180 days
measure: Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls
timeFrame: 180 days
measure: Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
timeFrame: Within 2-3 days of vaccination
measure: Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
timeFrame: Within 14 days of vaccination
Other outcomes:
Locations:
city: Alameda
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Antioch
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Clovis
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Daly City
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Davis
country: United States
facility: Kaiser Permanente
state: California
city: Fairfield
country: United States
facility: Kaiser Pediatric Injections
state: California
city: Folsom
country: United States
facility: Kaiser Permanente-Pediatrics
state: California
city: Fremont
country: United States
facility: Kaiser Permanente Adult Injection
state: California
city: Fremont
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Fresno
country: United States
facility: Kaiser Permanente Pediactrics
state: California
city: Gilroy
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Hayward
country: United States
facility: Kaiser Pediatric Injection Station
state: California
city: Lincoln
country: United States
facility: Kaiser Permanente
state: California
city: Livermore
country: United States
facility: Kaiser Pediatric Injection Station
state: California
city: Manteca
country: United States
facility: Kaiser Permanente Injection Clinic
state: California
city: Martinez
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Milpitas
country: United States
facility: Kaiser Permanente Adult Medicine
state: California
city: Milpitas
country: United States
facility: Kaiser Permanente Employee Health
state: California
city: Milpitas
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Modesto
country: United States
facility: Kaiser Permanente Injection Clinic
state: California
city: Modesto
country: United States
facility: Kaiser Permanente Medicine Dept.
state: California
city: Mountain View
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Napa
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Novato
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Employee Health
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Injection Clinic
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Regional Employee Health
state: California
city: Petaluma
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Pleasanton
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Rancho Cordova
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Adult Injection Clinic
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Roseville
country: United States
facility: Kaiser Permanente
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente, Point West Clinic Pediatric Injection
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente
state: California
city: Sacramento
country: United States
facility: Kaiser Pediatric Injection Station
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Medicine Dept.
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medicine Dept.
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Pharmacy
state: California
city: San Jose
country: United States
facility: Kaiser Pediatric Adult Medicine
state: California
city: San Jose
country: United States
facility: Kaiser Pediatric Injection Clinic
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente Employee Health
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Adult Medicine
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente Employee Health
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Selma
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Stockton
country: United States
facility: Kaiser Permanente Injection/Allergy
state: California
city: Tracy
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Vacaville
country: United States
facility: Kaiser Pediatric Injection Room
state: California
city: Vacaville
country: United States
facility: Kaiser Permanente Adult Medicine
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Injection Clinic
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Pediatric Injections
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Pediatrics
state: California
city: Arvada
country: United States
facility: Kaiser Permanente, Hidden Lake
state: Colorado
city: Aurora
country: United States
facility: Kaiser Permanente, Aurora Centrepoint
state: Colorado
city: Aurora
country: United States
facility: Kaiser Permanente, Smoky Hill
state: Colorado
city: Boulder
country: United States
facility: Kaiser Permanente, Baseline
state: Colorado
city: Boulder
country: United States
facility: Kaiser Permanente, Boulder
state: Colorado
city: Broomfield
country: United States
facility: Kaiser Permanente, Broomfield
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente, Skyline
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente, East
state: Colorado
city: Englewood
country: United States
facility: Kaiser Permanente, Englewood
state: Colorado
city: Highlands Ranch
country: United States
facility: Kaiser Permanente
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente
state: Colorado
city: Lakewood
country: United States
facility: Kaiser Permanente, Lakewood
state: Colorado
city: Littleton
country: United States
facility: Kaiser Permanente Arapahoe
state: Colorado
city: Littleton
country: United States
facility: Kaiser Permanente, Southwest
state: Colorado
city: Littleton
country: United States
facility: Kaiser Permanente, Ken Caryl
state: Colorado
city: Longmont
country: United States
facility: Kaiser Permanente, Longmont Primary Care
state: Colorado
city: Westminster
country: United States
facility: Kaiser Permanente, Westminster
state: Colorado
city: Wheatridge
country: United States
facility: Kaiser Permanente, Wheatridge
state: Colorado
Study officials:
affiliation: MedImmune LLC
name: Christopher Ambrose, M.D.
role: STUDY_DIRECTOR
References: