Study identifier:MI-MA162
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting
Healthy
Phase 4
Yes
-
All
29296
Observational
24 Months - 59 Months
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -
Verified 01 Mar 2012 by MedImmune, LLC
MedImmune, LLC
-
To assess the safety of FluMist vaccination
- 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.]
Location
Location
Oakland, CA, United States
Arms | Assigned Interventions |
---|---|
Active Comparator: 2 TIV | Biological/Vaccine: TIV (Injection) One or two injections of TIV depending on previous status. |
Active Comparator: 1 FluMist | Biological/Vaccine: FLuMist One or two vaccinations with FluMist depending on prior vaccination status. |
No Intervention: 3 Unvaccinated | Other: Unvaccinated Control no vaccine |
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