Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01201902
Status:
COMPLETED
Last Update Posted:
2010-09-20
First Post:
2010-09-13
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza AH1N1 Vaccine
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Randomized Open Clinical Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza AH1N1 Vaccine GC1116 With Adjuvant in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2010-09
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 purpose of this study is to assess the safety and the bodys immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination 354 individuals will be 18-64 years old and the other 236 will be greater than or equal to 65 years of age
Detailed Description:
ImmunogenicityEfficacy Outcome Measures Hemagglutination inhibition assay
1 Proportion of subjects stratified by group with seroconversion to HI antibody
2 Proportion of subjects stratified by group achieving a serum hemagglutination inhibition assayHIA antibody titer of 140 greater against the influenza H1N1 2009 virus
3 GMTGeometric Mean Titer and GMRGeometric Mean Ratio measuring by HIA antibody titer
Safety Outcome Measures
1 Solicited adverse eventsDay 0 6 Day 21 27 2 Unsolicited adverse eventsDay 0 42 3 Adverse eventsDay 21 6 months
1 Proportion of subjects stratified by group with seroconversion to HI antibody
2 Proportion of subjects stratified by group achieving a serum hemagglutination inhibition assayHIA antibody titer of 140 greater against the influenza H1N1 2009 virus
3 GMTGeometric Mean Titer and GMRGeometric Mean Ratio measuring by HIA antibody titer
Safety Outcome Measures
1 Solicited adverse eventsDay 0 6 Day 21 27 2 Unsolicited adverse eventsDay 0 42 3 Adverse eventsDay 21 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 임상제도과 - 649호2009928 | REGISTRY | Korea Food Drug Administraion | None |