A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine

Conditions
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Varicella

Intervention / Treatment
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* Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy child aged 1 year old (12-15 months old); Proven legal identity; The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment. Exclusion Criteria: History of vaccination of varicella vaccine or hepatitis A vaccine. Previous history of varicella infection or hepatitis A infection; History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc; Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition; Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc; Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before enrollment; Receipt of blood products within the past 3 months; Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine; Receipt of attenuated live vaccines in the past 28 days; Receipt of inactivated or subunit vaccines in the past 7 days; Onset of various acute or chronic diseases within 7 days prior to the study; Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The combined immunization group<br>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. | Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine<br>* 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.<br>|
| Active Comparator: The Non-combined immunization group<br>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. | Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |