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| Name | Class |
|---|---|
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
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The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
This trial is aim to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy people 1 to 12 years of age.1200 healthy subjects aged 1-12 years were enrolled after their guardians passed the informed consent, inclusion and exclusion criteria screening in turn. Three batches were randomized in a 1:1: 1 ratio, with 400 subjects in each batch.All subjects received 1 dose of trial vaccine (Batch 1 or Batch 2 or Batch 3) and all were collected Blood samples were collected from subjects before vaccination, on Day 30 after vaccination for serum neutralizing antibody testing to evaluate immunogenicity, and Safety observations were performed until 6 months post-vaccination in all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group1 | Experimental | Single subcutaneous injection of the investigational vaccine (0.5ml) |
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| Experimental Group2 | Experimental | Single subcutaneous injection of the investigational vaccine (0.5ml) |
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| Experimental Group3 | Experimental | Single subcutaneous injection of the investigational vaccine (0.5ml) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational live attenuated varicella vaccine (lot 1) | Biological | 0.5ml/vial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMT) of anti-VZV neutralizing antibodies | Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization | 30 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies | Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization | 30 days after vaccination |
| Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongxing Pan | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinyi Center for Disease Control and Prevention | Xuzhou | Jiangsu | 221600 | China |
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| Investigational live attenuated varicella vaccine (lot 2) |
| Biological |
0.5ml/vial |
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| Investigational live attenuated varicella vaccine (lot 3) | Biological | 0.5ml/vial |
|
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies 30 days after vaccination in the whole population |
| 30 days after vaccination |
| The incidences of adverse events (AEs) | AEs occurred witnin 30 days after vaccination will be collected | 30 days after vaccination |
| The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI) | SAEs and AESI occurred witnin 6 months after vaccination will be collected | 6 months after vaccination |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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