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This study aim to assess the immunogenicity and safety of interchangeable administration of the second dose of varicella vaccine. A total of 300 healthy participants aged 15 months - 12 years will be enrolled. Written informed consent form will be obtained from participants' parents or legally acceptable representatives (and assents will be obtained from participants aged above 9 years old and written consent forms will be prepared and consent will be obtained in writing if possible from the participants aged 3-8 years old.) before enrollment. Participants will be assigned to 5 groups according to the brand of first dose varicella vaccine they received at the age of 12 months. All participants will receive the second dose of varicella vaccine manufactured by Sinovac.
The duration of individual participation from enrollment to the last onsite visit will be a maximum of 42 days. The end of study is considered the completion of the last visit for the last participant in this study.
Blood samples (2.5 - 3.0ml per time) for immunogenicity assessment will be collected. The blood samples will be collected before vaccination and 42 days after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | The first dose administered was VARIVAX(varicella vaccine manufactured by Merck) |
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| Group 2 | Experimental | The first dose administered was VARILRIX(varicella vaccine manufactured by GSK) |
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| Group 3 | Experimental | The first dose administered was SUDUVAX(varicella vaccine manufactured by GC Biopharma) |
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| Group 4 | Experimental | The first dose administered was SKYVaricella(varicella vaccine manufactured by SK bioscience) |
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| Group 5 | Experimental | The first dose administered was PROVARIX(varicella vaccine manufactured by Sinovac) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROVARIX | Biological | Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) | |
| Geometric Mean Fold Rise (GMFR) of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive Rate of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) | |
| Seroresponse Rate of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akdeniz University Health, Research and Application Center (Hospital), Department of Child Health and Diseases, Department of Social Pediatrics | Recruiting | Akdeniz | Turkey (Türkiye) |
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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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| Incidence of Adverse Reactions Within 42 Days After Vaccination | Day 0 to Day 42 after vaccination |
| Incidence of Serious Adverse Events (SAEs) | Day 0 to Day 180 after vaccination |
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| Ankara Bilkent City Hospital, Pediatrics and Pediatric Infectious Diseases Clinic | Not yet recruiting | Ankara | Turkey (Türkiye) |
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| Hacettepe University Hospitals, Department of Pediatrics, Department of Social Pediatrics | Recruiting | Ankara | Turkey (Türkiye) |
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| REPUBLIC of TURKEY MINISTRY of HEALTH ANKARA BILKENT CITY HOSPITAL | Not yet recruiting | Ankara | Turkey (Türkiye) |
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| Ege University Hospital (Application and Research Center) Department of Child Health and Diseases | Not yet recruiting | Ege | Turkey (Türkiye) |
|
| D007239 | Infections |