Immunogenicity of Co-administration of Measles Containing Vaccine and Japanese Encephalitis Alive Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,043
- 试验地点
- 2
- 主要终点
- Seroconversion rate for measles
研究概览
简要总结
Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over other JE vaccines such as one dose schedule, using for infants, and the cheaper cost. Because the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it will likely be used in other countries, and possibly co-administered with the first dose of measles-containing vaccine (MCV) to ensure early protection and reduce additional vaccination visits.
The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited. Only one study conducted in the Philippines examining the co-administration of MCV with LJEV among 9 months infants, the results showed the proportion of achieved sero-protection against measles following MCV (96%) was slightly lower than in the MCV-only group (100%), and the measles antibody titres were also slightly lower in the co-administration group. Due to limited evidence available, the WHO position paper of measles vaccines has encouraged further investigation on the possible impact of co-administration of LJEV on measles vaccine effectiveness.
In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age nationally. Considering China is reaching towards the goal of measles elimination, it will be important to conduct a study to compare the immunogenicity of MR administered alone or with LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among 8 months infants.
This study is a prospective, randomized, open-label, multi-center study enrolling infants aged 8 months. Basic demographic information of the infant will be taken and blood samples will be collected at enrollment (baseline) and at 6weeks following administration of MR, the measles antibodies will be measured, and compare seroconversion rates to assess for non-inferiority. All infants will be monitored for adverse events after MR.
详细描述
Primary Objective:
- To determine whether sero-conversion rates against measles after co-administering measles-rubella (MR) vaccine and live attenuated JE vaccine at 8 months old are not lower than sero-conversion rates among those vaccinated with MR vaccine alone.
Secondary Objective:
- Sero-conversion rates against rubella after co-administering of MR vaccine and live attenuated JE vaccine at 8 months old are no less than those vaccinated with MR vaccine alone.
- To describe the incidence of adverse reactions in concurrent group and non-concurrent vaccination group after initial vaccination and during the follow-up period.
Subjects:
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
- 8 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants between 8 months and 8 months plus two weeks of age;
- •Complete vaccination of national immunization schedule before 8 months;
- •Healthy infants;
- •Live in the study county with good compliance who can participate in the entire observation period.
排除标准
- •Previous history of measles, rubella, or JE;
- •Previously received vaccines containing measles/rubella or JE components;
- •Contraindications to the study vaccines;
- •Received blood products or immunosuppressive treatments within last 3 months;
- •Received any live attenuated vaccines within the last 4 weeks, or any inactivated vaccines within 2 weeks;
- •Guardian refuses to participate in the study.
结局指标
主要结局
Seroconversion rate for measles
时间窗: 6 weeks after vaccination (day 42-48)
Compare the seroconversion rate of measles antibody between the two groups
次要结局
- Seroconversion rate for rubella(6 weeks after vaccination (day 42-48))
- Adverse Events Following Immunization(Within 6 weeks after vaccination)
研究者
Huaqing Wang
Deputy Director, National Immunization Program, China CDC
Centers for Disease Control and Prevention, China