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This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.
This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The combined immunization group | Experimental | 225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180. |
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| The Non-combined immunization group | Active Comparator | 225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The live attenuated varicella vaccine and the inactivated hepatitis A vaccine | Biological | The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd. The live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection. The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection. All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates of the varicella antibody | Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine. | 42 days after immunization of live attenuated varicella vaccine |
| Seroconversion rates of anti-HAV antibody | Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine. | 30 days after full immunization with hepatitis A vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive rates of varicella antibody | Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine. | 42 days after immunization of live attenuated varicella vaccine |
| GMT of varicella antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dianmin Kang | Shandong Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feicheng Center for Disease Control and Prevention | Tai’an | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36593652 | Derived | Sun D, Yu D, Du Z, Jia N, Liu X, Sun J, Xu Q, Sun Z, Luan C, Lv J, Xiong P, Zhang L, Sha X, Gao Y, Kang D. Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2161789. doi: 10.1080/21645515.2022.2161789. Epub 2023 Jan 2. |
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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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GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
| 42 days after immunization of live attenuated varicella vaccine |
| GMI of varicella antibody | GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine. | 42 days after immunization of live attenuated varicella vaccine |
| Seropositive rates of anti-HAV antibody | Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine. | 30 days after full immunization with hepatitis A vaccine |
| GMC of anti-HAV antibody | GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine. | 30 days after full immunization with hepatitis A vaccine |
| GMI of anti-HAV antibody | GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine. | 30 days after full immunization with hepatitis A vaccine |
| The incidence of adverse events | Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine. | within 0-42 days (or 0-30 days) after each dose of vaccine |
| The incidence of local and systemic solicitation adverse reactions | The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine. | Within 0-14 days (or 0-7 days) after each dose of vaccine |
| The incidence of serious adverse events (SAE) | The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine. | Within 42 days (or 30 days) after administration of each dose of vaccine |
| D007239 | Infections |