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| ID | Type | Description | Link |
|---|---|---|---|
| 임상제도과 - 649호(2009.9.28) | Registry Identifier | Korea Food & Drug Administraion |
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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.
▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay
Proportion of subjects, stratified by group, with seroconversion to HI antibody
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
GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer
1. Solicited adverse events(Day 0 ~ 6, Day 21 ~ 27) 2. Unsolicited adverse events(Day 0 ~ 42) 3. Adverse events(Day 21 ~ 6 months)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : Low dose with adjuvant | Experimental | Group 1: 18 ~ 64 years old subjects |
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| Group 1: High dose with adjuvant | Experimental | Group 1: 18 ~ 64 years old subjects |
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| Group1 : Plain vaccine | Active Comparator | Group 1: 18 ~ 64 years old subjects |
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| Group 2 : Low dose with adjuvant | Experimental | Group 2: greater than or equal to 65 years of age |
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| Group 2 : high dose with adjuvant | Experimental | Group 2: greater than or equal to 65 years of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted influenza A(H1N1) vaccine | Biological | 0.25ml, Intramuscular on Day 0 and 21 |
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| Measure | Description | Time Frame |
|---|---|---|
| HI antibody responses after 1 and/or 2 vaccinations | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination | the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination |
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Inclusion Criteria:
Exclusion Criteria:
C. Received an experimental agent within 1 month prior to vaccination in this study.
D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)
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| Name | Affiliation | Role |
|---|---|---|
| Woo-ju Kim | Korea University Guro Hospital | Principal Investigator |
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| Adjuvanted influenza A(H1N1) vaccine | Biological | 0.5ml, Intramuscular on Day 0 and 21 |
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| un-adjuvanted influenza A(H1N1) vaccine | Biological | 0.5ml, Intramuscular on Day 0 and 21 |
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| Adjuvanted influenza A(H1N1) vaccine | Biological | 0.25ml, Intramuscular on Day 0 and 21 |
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| Adjuvanted influenza A(H1N1) vaccine | Biological | 0.5ml, Intramuscular on Day 0 and 21 |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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