NCT07054099招募中3 期
A Phase III, Double-blind, Randomized, Multicenter, Multinational, Active-controlled, Non-inferiority Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Proportion of participants who achieved seroconversion at 42 days after second vaccination
研究概览
简要总结
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent.
- •Participant is overtly healthy as determined by the investigator
排除标准
- •Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening
- •Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV
- •Participants with acute moderate or severe infection with or without fever at the time of dosing
- •Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product
研究组 & 干预措施
MG1111 (Barycela inj.)
Experimental
干预措施: MG1111 (Barycela inj.) (Biological)
Varivax™
Active Comparator
干预措施: VARIVAX™ (Biological)
结局指标
主要结局
Proportion of participants who achieved seroconversion at 42 days after second vaccination
时间窗: 42 days after second vaccination
次要结局
- Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX(7 days after each vaccination)
- Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX(6 months after second vaccination)
- Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX(42 days after each vaccination)
研究者
研究点 (1)
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