NCT04364399已完成4 期
Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8 ~12 Months.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 920
- 试验地点
- 1
- 主要终点
- The seroconversion rate of hemagglutination inhibition (HI) antibody
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).
详细描述
The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 8 - 12 months old;
- •Proven legal identity;
- •Written consent of the guardian(s) of the volunteer
排除标准
- •Received mumps vaccine or vaccine containing mumps virus;
- •History of mumps;
- •Axillary temperature > 37.4 °C;
- •History of allergy to any vaccine or vaccine ingredient;
- •History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- •Autoimmune disease or immunodeficiency or immunosuppression;
- •Congenital malformation, genetic defects, severe malnutrition;
- •Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- •Severe chronic diseases (e.g., severe cardiovascular disease, liver and kidney disease beyond the control of drugs, or cancer)
- •Severe neurological disorders (epilepsy, seizures or convulsions) or psychosis;
- •History of thyroidectomy, absence of spleen, functional absence of spleen, and any condition resulting from absence of spleen or splenectomy;
- •Receipt of any of the following products:
- •Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- •Any live attenuated vaccine within 28 days prior to study entry;
- •Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
- •Blood product within 3 months prior to study entry;
- •Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
- •Any of the acute disease or attack of the chronic disease within 7 days;
- •Pregnant in cohabitants or congenital immune diseases;
- •Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded
结局指标
主要结局
The seroconversion rate of hemagglutination inhibition (HI) antibody
时间窗: the 30th day after vaccination
Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine
次要结局
- The incidence of the unsolicited adverse events(from day 0 to day 30 after immunization)
- The GMT of HI antibody(the 30th day after vaccination)
- The incidence of the solicited local and systemic adverse reactions(from day 0 to day 14 after vaccination)
- The incidence of the serious adverse events(from day 0 to day 30 after immunization)
研究者
研究点 (1)
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