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This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No vaccination history group | Experimental | Participants aged 1-12 years with no vaccination history of varicella-containing vaccine |
|
| Vaccination history group | Experimental | Participants aged 2-12 years have received 1 dose of varicella vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Vaccine | Biological | Varicella vaccine manufactured by Sinovac |
|
| Measure | Description | Time Frame |
|---|---|---|
| The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history | 42 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history | 42 days after vaccination | |
| The Geometric Mean Concentration(GMC) of VZV antibodies in total population | 42 days after vaccination |
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Inclusion Criteria:
Healthy children aged 1-12 years;
Vaccination history:
Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
Participants are able to comply with the study procedures based on the assessment of the investigator;
Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pham Thi Van Anh | Contact | +84- 915 595 690 | phamthivananh.hmu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Medical University | Hanoi | 100000 | 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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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| The seropositive rate of VZV antibodies in total population | 42 days after vaccination |
| The geometric mean fold rise (GMFR) of VZV antibodies in total population | 42 days after vaccination |
| The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history | 42 days after vaccination |
| The geometric mean concentration (GMC) of VZV antibodies among population with varicella immunization history | 42 days after vaccination |
| The seropositive rate of VZV antibodies among population with varicella immunization history | 42 days after vaccination |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |