Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192179
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2005-09-12
Brief Title:
A Phase II Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase II Prospective Randomized Double-Blind Placebo Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine Trivalent Types A B Live Cold-Adapted Liquid Formulation CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years
Status:
COMPLETED
Status Verified Date:
2012-02
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:
FluMist
Brief Summary:
A safety study to compare over a 7 day period the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years
Detailed Description:
This was a prospective randomized double-blind placebo-controlled study Subjects were randomized to receive either CAIV-T or Placebo All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment
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