A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Seroconversion rates of the varicella antibody
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Seroconversion rates of the varicella antibody
时间窗: 42 days after immunization of live attenuated varicella vaccine
Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Seroconversion rates of anti-HAV antibody
时间窗: 30 days after full immunization with hepatitis A vaccine
Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
次要结局
- Seropositive rates of varicella antibody(42 days after immunization of live attenuated varicella vaccine)
- The incidence of serious adverse events (SAE)(Within 42 days (or 30 days) after administration of each dose of vaccine)
- GMI of varicella antibody(42 days after immunization of live attenuated varicella vaccine)
- GMC of anti-HAV antibody(30 days after full immunization with hepatitis A vaccine)
- GMI of anti-HAV antibody(30 days after full immunization with hepatitis A vaccine)
- GMT of varicella antibody(42 days after immunization of live attenuated varicella vaccine)
- Seropositive rates of anti-HAV antibody(30 days after full immunization with hepatitis A vaccine)
- The incidence of adverse events(within 0-42 days (or 0-30 days) after each dose of vaccine)
- The incidence of local and systemic solicitation adverse reactions(Within 0-14 days (or 0-7 days) after each dose of vaccine)