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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00113880
First received: June 10, 2005
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Healthy
Biological: FluMist

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.

  • Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.

  • Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.

  • Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups. [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.

  • Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.

  • Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.

  • Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.

  • Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.

  • Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.

  • Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.

  • Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls [ Time Frame: 21 and 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.

  • Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.

  • Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.


Secondary Outcome Measures:
  • 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 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.

  • 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 [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.

  • 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 [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.

  • 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 [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.

  • 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 [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.

  • 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 [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.

  • Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) [ Time Frame: Within 2-3 days of vaccination ] [ Designated as safety issue: Yes ]
  • Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season) [ Time Frame: Within 14 days of vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 63061
Study Start Date: October 2003
Study Completion Date: June 2010
Primary Completion Date: September 2008 (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

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

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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 77 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Christopher Ambrose, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00113880     History of Changes
Other Study ID Numbers: FM025
Study First Received: June 10, 2005
Results First Received: April 2, 2012
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 22, 2014