Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192140
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-09-09
Brief Title:
Trial to Assess the SheddingImmunogenicity and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
An Open-Label Single-Arm Trial to Assess the Shedding Immunogenicity and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age
Status:
COMPLETED
Status Verified Date:
2007-12
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:
To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses
To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age
To describe the genotypic and phenotypic stability of shed vaccine viruses
To describe the immune responses of FluMist in individuals 5-49 years of age
To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response
To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age
To describe the genotypic and phenotypic stability of shed vaccine viruses
To describe the immune responses of FluMist in individuals 5-49 years of age
To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response
Detailed Description:
The purpose of this study is to evaluate the viral shedding immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age
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