A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,140
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCRs) of susceptible subjects in each group
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.
详细描述
This study is a randomized, blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is a commercialized live attenuated mumps vaccine manufactured by ZheJiang VACN bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer between 8 - 18 months old;
- •Proven legal identity;
- •Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study;
- •Complying with the requirement of the study protocol;
排除标准
- •Axillaty temperature > 37.0 °C;
- •Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Prior vaccination with mumps vaccine or with history of mumps infection;
- •History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- •Receipt of any of the following products:
- •Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
- •Any live attenuated vaccine within 28 days prior to study entry;
- •Any other investigational medicine(s) within 30 days prior to study entry;
- •Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
- •Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
- •Epilepsy (except febrile seizures), history of seizures or convulsions, or a family history of mental illness;
- •Autoimmune disease or immunodeficiency;
- •Congenital malformation, developmental disorders, or serious chronic diseases (e.g., Down's syndrome, diabetes, sickle cell anemia or neurological disorders);
- •Severe malnutrition;
- •Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities);
- •Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
- •Participants with the following conditions between day 0 - 28 of this study would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):
- •Receipt of any other investigational or unregistered product (drug or vaccine);
- •Receipt of immunosuppressant (dosage of corticosteroid ≥ that in 0.5 mg prednisone per kg weight per day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid;
- •Receipt of immunoglobulin and/or other blood product;
- •Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
研究组 & 干预措施
Experimental Group
- Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
- Intervention: investigational live attenuated mumps vaccine;
干预措施: Investigational live attenuated mumps vaccine (Biological)
Control Group
- Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
- Intervention: control live attenuated mumps vaccine;
干预措施: control live attenuated mumps vaccine (Biological)
结局指标
主要结局
The seroconversion rates (SCRs) of susceptible subjects in each group
时间窗: 28 days
Subjects whose pre-immune HI antibody level \< 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted.
次要结局
- The post-immune geometric mean titers (GMTs) of susceptible subjects in each group(28 days)
- The incidences of adverse events (AEs) of each group(28 days)
- The incidences of serious adverse events (SAEs) of each group(28 days)
- The overall SCRs of each group(28 days)
- The overall post-immune GMTs of each group(28 days)