Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-15 @ 3:39 AM
Study NCT ID:
NCT01201902
Status:
COMPLETED
Last Update Posted:
2010-09-20
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
Sponsor:
Green Cross Corporation
Organization:
Study Overview
Official Title:
Randomized, Open, Clinical Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) 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 body's 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:
▶ Immunogenicity(Efficacy) 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 assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus
3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer
* Safety Outcome Measures :
1\. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 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 assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus
3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer
* Safety Outcome Measures :
1\. Solicited adverse events(Day 0 \~ 6, Day 21 \~ 27) 2. Unsolicited adverse events(Day 0 \~ 42) 3. Adverse events(Day 21 \~ 6 months)
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 임상제도과 - 649호(2009.9.28) | REGISTRY | Korea Food & Drug Administraion | View |