a study of combined immunization with live attenuated varicella vaccine and inactivated hepatitis a vaccine

Conditions: Varicella

Summary: 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.

Eligibility criteria:
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