Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192127
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2005-09-12
Brief Title:
Study to Evaluate the Safety of a Bivalent Vaccine of New 62 Influenza Virus Reassortants in Healthy Adults
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Prospective Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 62 Influenza Virus Reassortants in Healthy Adults
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:
This study is to assess the safety of a bivalent vaccine of two new 62 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine FluMist containing them
Detailed Description:
The primary study objective is to assess the safety of a bivalent vaccine of two new 62 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine FluMist containing them Safety will be demonstrated by similar fever rates oral temperature 101F Days 0-7 in vaccine and placebo recipients
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