Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192257
Status:
COMPLETED
Last Update Posted:
2006-10-03
First Post:
2005-09-12
Brief Title:
Trial to Compare the Safety Tolerability and Efficacy of Influenza Virus Vaccine CAIV-T With Influenza Virus in Children With Asthma
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Prospective Randomized Open-Label Controlled Trial to Compare the Safety Tolerability and Efficacy of Influenza Virus Vaccine Trivalent Type AB Live Cold-Adapted CAIV-T With Influenza Virus Vaccine Trivalent Inactivated TIV in Children With Asthma Aged 6 Years to 17 Years
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
- Trial to assess asthma exacerbation through to the end of the study and to demonstrate that the efficacy over one season against culture-confirmed influenza-illness and finally to assess the safety and tolerability of CAIV-T in children with asthma
Detailed Description:
- To assess asthma exacerbation being defined as acute wheezing illness associated with hospitalization unscheduled clinic visits or new prescriptions from study vaccination through to the end of the study
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