Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113880
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2005-06-10
Brief Title:
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None