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| Name | Class |
|---|---|
| Vabiotech | INDUSTRY |
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This is a cross-over, open-label, single-group study. The study subjects were children 12 months to 12 years of age who will be vaccinated with a single dose. The duration of follow-up for safety evaluation and immunogenicity (on a small group) is 6 weeks (+ 2 weeks).
The main target:
• Evaluating the safety of live attenuated Varicella vaccine [Oka / SK], lyophilized powder and solvent for subcutaneous injection (SKYVaricella inj.) in healthy Vietnamese children from 12 months to 12 years, with a single injection.
Secondary target:
• Assess the immunogenicity of live attenuated Varicella vaccine [Oka / SK], lyophilized powder and solvent for subcutaneous injection (SKYVaricella inj.) in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.
The Safety of Skyvaricella Injection:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluating the Safety of Skyvaricella Inj. | Experimental | The main target: • Evaluating the safety of Live Attenuated Varicella Vaccine SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection |
|
| Evaluating the Immunogenicity of Skyvaricella Inj. | Experimental | Secondary target • Evaluating the immunogenicity of Live Attenuated Varicella Vaccine SKYVaricella injection in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skyvaricella Injection | Biological | The main target is evaluating the safety of SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection. The secondary target is to Assess the immunogenicity of SKYVaricella inj. in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection. |
| Measure | Description | Time Frame |
|---|---|---|
| the Safety of Skyvaricella Injection | The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated). | between 1 and 6 weeks after vaccination |
| the Safety of Skyvaricella Injection | The incidence and severity of events (local and systemic) | within 30 minutes after vaccination |
| the Safety of Skyvaricella Inj. | The incidence of expected systemic and local adverse events | within 7 days after vaccination |
| the Safety of Skyvaricella Injection | The incidence of serious adverse events and Unexpected adverse events | within 6 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| the Immunogenicity of Skyvaricella Injection | seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test | 6 weeks after investigational vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pham N Hung, As. Prof. | Vietnam Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CDC Ha Nam | Phu Ly | Ha Nam | 18000 | Vietnam |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| D007239 | Infections |