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Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and adults Aged 13-55 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Attenuated Varicella vaccine candidates | Experimental | freezedried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers. |
|
| Marketed Live Attenuated Varicella vaccine | Active Comparator | the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chickenpox Vaccines | Biological | The vaccines require reconstitution with the provided sterile water for injection nd should be shaken well before use. Each human dose (0.5 ml) contains at least 3.3 log PFU of VZV. |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rate | The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies | 42 days after completing the full course of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| geometric mean titer (GMT) | geometric mean titer (GMT) of VZV antibodies 42 days after vaccination | 42 days after completing the full course of vaccination |
| geometric mean fold increase (GMFI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huaiyin District Center for Disease Control and prevention | Huaian | Jiangsu | 223399 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39916494 | Derived | Zhang Y, Wang S, Li G, Shi J, Chang X, Zhang H, Zhu F, Li J, Pan H, Sun J. Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase III clinical trial in China. Expert Rev Vaccines. 2025 Dec;24(1):157-164. doi: 10.1080/14760584.2025.2457463. Epub 2025 Feb 7. |
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geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination
| 42 days after completing the full course of vaccination |
| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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