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This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.
A total of 720 children aged 18~24 months who have not received varicella vaccine, the second dose of MMR and the fourth dose of DTaP (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group A, Group B and Group C. Participants in Group A will receive varicella vaccine and DTaP simultaneously on Day 0 and receive MMR on Day 30. Participants in Group B will varicella vaccine and MMR simultaneously on Day 0 and receive DTaP on Day 30. Participants in Group C will receive varicella vaccine only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Varicella vaccine and DTaP co-administration group ) | Experimental | Participants will receive a single dose of varicella vaccine and DTaP vaccine on Day 0 and a single dose of MMR on Day 30. |
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| Group B (Varicella vaccine and MMR co-administration group ) | Experimental | Participants will receive a single dose of varicella vaccine and MMR on Day 0 and DTaP vaccine on Day 30. |
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| Group C (Varicella vaccine group ) | Active Comparator | Participants will receive a single dose of varicella vaccine on Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaicella Vaccine+DTaP on Day 0, MMR on Day 30 | Biological | Varicella vaccine: lyophilized powder, subcutaneous injection DTaP: intramuscular injection MMR: lyophilized powder, subcutaneous injection |
| Measure | Description | Time Frame |
|---|---|---|
| Varicella zoster virus (VZV) antibody seroconversion rate | Seroconversion rate of VZV antibody on Day 30 after the administration of varicella vaccine. | Day 30 after the administration of varicella vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive rate of VZV antibody | Seropositive rate of VZV antibody on Day 30 after the administration of varicella vaccine. | Day 30 after the administration of varicella vaccine |
| Geometric mean titer (GMT) of VZV antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XU Jiawei | Contact | 023-68813088 | 452712782@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Center for Disease Control and Prevention | Chongqing | 400042 | China |
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| Varicella vaccine+MMR on Day 0,DTaP on Day 30 | Biological | Varicella vaccine: lyophilized powder, subcutaneous injection MMR: lyophilized powder, subcutaneous injection DTaP: intramuscular injection |
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| Varicella Vaccine | Biological | lyophilized powder, subcutaneous injection |
|
GMT of VZV antibody on Day 30 after the administration of varicella vaccine.
| Day 30 after the administration of varicella vaccine |
| Geometric mean fold increase (GMI) of VZV antibody | GMI of VZV antibody on Day 30 after the administration of varicella vaccine. | Day 30 after the administration of varicella vaccine |
| Seroconversion rate of measles antibody, mumps antibody and rubella antibody | Seroconversion rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR | Day 30 after the administration of MMR |
| Seropositive rate of measles antibody, mumps antibody and rubella antibody | Seropositive rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR | Day 30 after the administration of MMR |
| Geometric mean concentration (GMC) of measles antibody, mumps antibody and rubella antibody | GMC of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR | Day 30 after the administration of MMR |
| GMI of measles antibody, mumps antibody and rubella antibody | GMI of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR | Day 30 after the administration of MMR |
| Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody | Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP | Day 30 after the administration of DTaP |
| Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody | Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP | Day 30 after the administration of DTaP |
| GMC of pertussis antibody, diphtheria antibody and tetanus antibody | GMC of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP | Day 30 after the administration of DTaP |
| GMI of pertussis antibody, diphtheria antibody and tetanus antibody | GMI of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP | Day 30 after the administration of DTaP |
| The incidence of adverse reactions within 0~14 days | The incidence of adverse reactions within 0~14 days after each dose vaccination. | 0~14 days after each dose vaccination |
| The incidence of adverse reactions within 0~30 days | The incidence of adverse reactions within 0~30 days after each dose vaccination. | 0~30 days after each dose vaccination |
| The incidence of serious adverse events (SAEs) within 0~30 days | The incidence of SAEs within 0~30 days after each dose vaccination. | 0~30 days after each dose 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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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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