Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 873
- 试验地点
- 4
- 主要终点
- Immunogenicity of the MMR vaccines in terms of antibody concentration
研究概览
简要总结
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).
详细描述
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older.
The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR.
Immune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time.
Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent;
- •undiagnosed as measles, mumps and rubella;
- •in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization;
- •guardians would comply with the requirements of the protocol;
- •immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month;
- •Axillary temperature ≤37℃;
- •the local household population or permanent population;
排除标准
- •history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history);
- •Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases;
- •Participating in another clinical trial at the same time;
研究组 & 干预措施
one dose of MMR
Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old.
干预措施: Measles, mumps and rubella Combined Vaccine, Live (Biological)
30 months after two doses of MMR
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially.
干预措施: Measles, mumps and rubella Combined Vaccine, Live (Biological)
42 months after two doses of MMR
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially.
干预措施: Measles, mumps and rubella Combined Vaccine, Live (Biological)
54 months after two doses of MMR
Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially.
干预措施: Measles, mumps and rubella Combined Vaccine, Live (Biological)
结局指标
主要结局
Immunogenicity of the MMR vaccines in terms of antibody concentration
时间窗: through study completion, an average of 1 year
For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) \>200 mIU/mL. For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc \>100 IU/mL. For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc \>20 IU/mL.
次要结局
未报告次要终点
研究者
Wu Jiang
Director of Department of Immunization and Prevention,Beijing Center for Disease Control and Prevention. Principal Investigator, Public Health Chief Physician
Centers for Disease Control and Prevention, China