Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192270
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2005-09-12
Brief Title:
Trial to Assess Safety Tolerability and Immunogenicity of Influenza Virus Vaccine Trivalent Types A and B Live Cold-adapted CAIV-T in Healthy Children
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Prospective Open-label Phase II Multi-center Study of the Safety Tolerability and Immunogenicity of Influenza Virus Vaccine Trivalent Types A and B Live Cold-adapted CAIV-T in Healthy Children Aged 6 to 17 Years
Status:
COMPLETED
Status Verified Date:
2012-03
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:
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group
Detailed Description:
This was a phase II prospective open-label multicenter outpatient study designed to evaluate the safety tolerability and immunogenicity of one or two doses of CAIV-T in children and adolescents between 6 and 17 years of age Subjects were allocated to one of three study groups according to age at the time of enrollment study group one consisted of subjects between 6 and 9 years of age group two of subjects 10 to 12 years of age and group three of subjects 13 to 17 years of age
Approximately 450 subjects ie 150 subjects per age group participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 7 days in an open-label manner
Approximately 450 subjects ie 150 subjects per age group participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 7 days in an open-label manner
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