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The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study vaccine (AdimFlu-W) | Experimental | 0.5 mL/dose, a total of 2 doses, 21 days apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandemic Influenza Vaccine (H5N1) | Biological | Inactivated whole-virion vaccine
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Endpoint: hemagglutination inhibition (HAI) titer and microneutralization (MN) titer | The primary immune response endpoint is to evaluate the seroconversion rate (SCR) in terms of HAI assays at Day 43 (21 days after the second dose).The secondary HAI endpoints are defined as following:
The supportive immunogenicity endpoints of MN antibodies are SCRs, SPRs and GMFRs at Day 22 and 43. | At Day 43 (21 days after the second dose). |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events after vaccination. | Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Jen Chang, MD | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Taiwan |
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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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| At 4 weeks after two doses of study vaccine, 4 weeks apart. Reactogenicity will be recorded for 7 days after each vaccination. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |