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The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza Vaccine | Experimental | One dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection into the musculus deltoideus in the upper arm on Day 1 and 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005) | Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2 | Day 43 (42 days after first vaccination, 21 days after second vaccination) |
| Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination | 'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample (≤4mm^2) or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2. | Day 43 (42 days after first vaccination, 21 days after second vaccination) |
| Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline | Day 43 (42 days after first vaccination, 21 days after second vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005) | Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2 | Days 22 and 202 |
| Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirjhar Chatterjee, MD | Baxter Innovations GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PS Clinic | Fukuoka | 812-0025 | Japan | |||
| Osaka Pharmacology Clinical Research Hospital (OPHAC Hospital) |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample [≤4mm^2] or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2. |
| Days 22 and 202 |
| Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline | Days 22 and 202 |
| Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005) | Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20 | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination | 'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline. | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating either ≥4-fold titer increase compared to baseline if above detection limit OR ≥ 20 titer after vaccination if baseline titer is below detection limit | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005) | Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40 | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination | 'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination | Days 22, 43 and 202 |
| Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline | Days 22, 43 and 202 |
| Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations | Through study day 43 |
| Number of participants with fever, malaise or shivering with onset within 7 days after the first and second vaccinations | Days 1-8 and days 22-29 |
| Frequency and severity of all adverse events (AEs) observed during the entire study period | Throughout the study period- 8 months |
| Osaka |
| 532-0003 |
| Japan |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |