Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424086
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2007-01-17
Brief Title:
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine Split Virus Vero Cell Derived
Sponsor:
Resilience Government Services Inc
Organization:
Resilience Government Services Inc
Study Overview
Official Title:
Single Blind Randomized Actively Controlled Phase 12 Study to Compare the Safety and Immunogenicity of a Split Virus Vero Cell Derived Seasonal Influenza Vaccine VCIC With a Licensed Egg Derived Split Virus Seasonal Influenza Vaccine EIV
Status:
COMPLETED
Status Verified Date:
2008-01
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:
The objective of this study is to assess the safety tolerability and immunogenicity of a Split Virus Vero Cell derived Seasonal Influenza Vaccine VCIV in comparison to a Licensed Egg Derived Split Virus Seasonal Influenza Vaccine EIV in healthy subjects 18 years of age and older
Approximately 1000 subjects will be randomly assigned in a 31 ratio to receive a single injection of VCIV or EIV Subjects will be monitored for 180 days following vaccination for occurrence of adverse reactions and for antibody response to the vaccine
Approximately 1000 subjects will be randomly assigned in a 31 ratio to receive a single injection of VCIV or EIV Subjects will be monitored for 180 days following vaccination for occurrence of adverse reactions and for antibody response to the vaccine
Detailed Description:
None
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