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The goal of this clinical trial is to evaluate the immunogenicity of simultaneous administration of varicella live attenuated vaccine (varicella vaccine hereafter) and trivalent inactivated influenza vaccine (TIV hereafter). It will also evaluate the safety of simultaneous administration of the two vaccines. The main questions it aims to answer are:
Participants in the simultaneous administration group received a single dose of varicella vaccine and TIV simultaneously on day 0. Participants in the separate groups received a single dose of varicella vaccine or TIV on day 0, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous vaccination group | Experimental | Participants received a single dose of varicella vaccine and TIV on Day 0. |
|
| Varicella vaccine separate group | Active Comparator | Participants received a single dose of varicella vaccine on Day 0. |
|
| TIV separate group | Active Comparator | Participants received a single dose of TIV on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella vaccine+TIV | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT of VZV antibody | GMT of VZV antibody on Day 30 after the vaccination. | Day 30 after the vaccination |
| GMT of HI antibody | GMT of HI antibody on Day 30 after vaccination. | Day 30 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean increase (GMI) of VZV antibody | GMI of VZV antibody on Day 30 after the vaccination. | Day 30 after the vaccination |
| Seroconversion rate of VZV antibody | Seroconversion rate of VZV antibody on Day 30 after the vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease control and Prevention | Nanjing | Jiangsu | 210009 | China |
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| Varicella vaccine | Biological | lyophilized powder, subcutaneous |
|
| TIV | Biological | Inactived, split virion, containing H1N1, H3N2 and BV strains. |
|
| Day 30 after the vaccination |
| Seropositive rate of VZV antibody | Seropositive rate of VZV antibody on Day 30 after the vaccination. | Day 30 after the vaccination |
| GMI of HI antibody | GMI of HI antibody on Day 30 after the vaccination. | Day 30 after the vaccination |
| Seroconversion rate of HI antibody | Seroconversion rate of HI antibody on Day 30 after the vaccination. | Day 30 after the vaccination |
| Seroprotection rate of HI antibody | Seroprotection rate of HI antibody on Day 30 after the vaccination. | Day 30 after the vaccination |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
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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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