NCT05161845已完成4 期
A Phase IV Randomized, Blinded Clinical Trial to Assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) Lot-to-lot Consistency in Healthy Chinese Children at the Age of 8-12 Months
Shanghai Institute Of Biological Products1 个研究点 分布在 1 个国家目标入组 1,068 人开始时间: 2021年12月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,068
- 试验地点
- 1
- 主要终点
- The geometric mean concentrations (GMC)
研究概览
简要总结
To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
详细描述
To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in healthy Chinese Children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Provide vaccination certificate and birth certificate for healthy children aged 8-12 months;
- •Volunteers' legal guardian informed consent, volunteered to participate and signed an informed consent form；
- •The volunteer's legal guardian has the ability to understand the research procedures, use the thermometer, scale and fill in the diary card as required, and can complete the clinical study in accordance with the requirements of the clinical trial protocol.
排除标准
- •The axillary body temperature on the day of enrollment was more than 37.0 ℃;
- •Have suffered from measles, mumps and rubella in the past or are suffering from measles, mumps and rubella;
- •Any previous vaccination containing measles, mumps and rubella;
- •Persons known to be allergic to any ingredient in the investigational vaccine;
- •Any previous history of vaccine or drug allergy;
- •Premature (delivered before the 37th week of pregnancy) and low weight (birth weight < 2500g);
- •History of dystocia, asphyxia rescue and nervous system damage;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- •Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination;
- •Have a history of live attenuated vaccine within 28 days before vaccination and other vaccines within 7 days;
- •Those who receive immune enhancement or inhibitor treatment within 3 months (continuous oral or drip for more than 14 days);
- •Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- •History of asthma, unstable in the past two years, requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids;
- •Have received blood or blood related products;
- •Patients with progressive nervous system diseases have a history of convulsion, epilepsy, encephalopathy, GuillainBarre syndrome, mental history or family history;
- •Have a history of abnormal coagulation function (such as coagulation factor deficiency and coagulation diseases);
- •Plan to move out before the end of the study or leave for a long time during the scheduled study visit;
- •Participating in or planning to participate in other clinical trials in the near future;
- •The investigator judges any situation that is not suitable to participate in this clinical trial.
结局指标
主要结局
The geometric mean concentrations (GMC)
时间窗: 42 days
GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).
次要结局
- The positive conversion rate of antibodies(42 days)
- Serious adverse events(180 days)
- The incidence of adverse events within 14 days(14 days)
- All adverse events(42 days)
- The Seropositivity rate(42 days)
研究者
研究点 (1)
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