A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
NCT ID: NCT00626808
Last Updated: 2014-08-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
321697 participants
OBSERVATIONAL
2007-10-31
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program
NCT00192218
A Phase 2 Study to Evaluate Immune Responses of FluMist®
NCT00461981
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
NCT00113880
A Post Marking Study to Evaluate the Safety of FluMist in Children
NCT00569894
Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment
NCT00138385
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Children younger than 24 months of age
* Children 24-59 months of age with a claim associated with a diagnosis of asthma
* Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
* Children 24-59 months of age with immunosuppression
* To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
* To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Children less than 24 months of age
No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
2
Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
3
Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
4
Children 24-59 months of age with immunosuppression
No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Children \<24 to 59 months of age during August through January/February, with:
* two outpatient claims for asthma, or
* one inpatient/emergency room claim for asthma, or
* one outpatient claim for asthma and at least one SABA prescription during a defined 12-month period.
* Children \<24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
* Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RTI International
OTHER
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chris Ambrose, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Research Triangle Park, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MI-MA175
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.