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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00569894
First received: December 6, 2007
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

To assess the safety of FluMist vaccination


Condition Intervention Phase
Healthy
Biological: FLuMist
Biological: TIV (Injection)
Other: Unvaccinated Control
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 29296
Study Start Date: October 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2
TIV
Biological: TIV (Injection)
One or two injections of TIV depending on previous status.
1
FluMist
Biological: FLuMist
One or two vaccinations with FluMist depending on prior vaccination status.
3
Unvaccinated
Other: Unvaccinated Control
no vaccine

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.]
  Eligibility

Ages Eligible for Study:   24 Months to 59 Months
Genders Eligible for Study:   Both
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.

Criteria

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.
  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: NCT00569894

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

Additional Information:
No publications provided

Responsible Party: Medical Monitor, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00569894     History of Changes
Other Study ID Numbers: MI-MA162
Study First Received: December 6, 2007
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 16, 2014