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A Post Marking Study to Evaluate the Safety of FluMist in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00569894
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : March 8, 2012
Information provided by:
MedImmune LLC

Brief Summary:
To assess the safety of FluMist vaccination

Condition or disease Intervention/treatment Phase
Healthy Biological: FLuMist Biological: TIV (Injection) Other: Unvaccinated Control Phase 4

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.]

Study Type : Observational
Actual Enrollment : 29296 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting
Study Start Date : October 2007
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot
U.S. FDA Resources

Group/Cohort Intervention/treatment
Biological: TIV (Injection)
One or two injections of TIV depending on previous status.
Biological: FLuMist
One or two vaccinations with FluMist depending on prior vaccination status.
Other: Unvaccinated Control
no vaccine

Primary Outcome Measures :
  1. Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting. [ Time Frame: 1, 3, 21, or 42 days post dose; 6 months post dose; entire study period) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569894

United States, California
Research Site
Oakland, California, United States
Sponsors and Collaborators
MedImmune LLC
Study Director: Seth Toback, M.D. MedImmune LLC

Additional Information:
Responsible Party: Medical Monitor, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00569894     History of Changes
Other Study ID Numbers: MI-MA162
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012