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| Name | Class |
|---|---|
| Baxter Innovations GmbH | INDUSTRY |
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The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group I / Intramuscular | Experimental | 85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22 |
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| Treatment group II / Intramuscular | Experimental | 85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22 |
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| Treatment group III / Subcutaneous | Experimental | 85 subjects to receive 2 subcutaneous vaccinations at Dose A on Days 1 and 22 |
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| Treatment group IV / Subcutaneous | Experimental | 85 subjects to receive 2 subcutaneous vaccinations at Dose B on Days 1 and 22 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) | Biological | Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with antibody response to the vaccine strain | Measurement by single radial hemolysis (SRH) assay | 21 days after 2nd vaccination |
| Number of subjects demonstrating seroconversion | Measurement by SRH assay | 21 days after 2nd vaccination |
| Fold increase of antibody response | Measurement by SRH assay | 21 days after 2nd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with antibody response to the vaccine strain | Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay | 21 days after 1st and 21+180 days after 2nd vaccination |
| Number of subjects demonstrating seroconversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Geisberger, MD | Baxter Innovations GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Co. LTA PS Clinic | Fukuoka | Fukuoka | 812-0025 | Japan | ||
| CPC Clinic, Medipolis Medical Research Institute |
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| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay |
| 21 days after 1st and 21+180 days after 2nd vaccination |
| Antibody response | Measurement by SRH, MN and HI assay | 21 days after 1st and 21 + 180 days after 2nd vaccination |
| Fold increase of antibody response | Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay | 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline |
| Kagoshima |
| Kagoshima-ken |
| 890-0081 |
| Japan |
| Osaka Pharmacology Clinical Research Hospital | Osaka | Osaka | 532-0003 | Japan |
| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |