JPRN-jRCT2080222978已完成1 期
An open-label, randomized, clinical study assessing the safety and immunogenicity of JVC-001 in Japanese healthy children
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
JVC-001 or control vaccines were injected once each subcutaneously in Japanese healthy children. Day 42, antibody titers against measles, rubella and mumps viruses antigens were measured. Seroconversion rate of antibodies against measles virus and rubella virus were 100% in both groups, and seroresponse rate and GMT for anti-mumps virus antibody by the unenhanced PRNT method were at sufficient levels in both groups. The incident of most AEs were comparable in both groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 1age old 至 <= 2age old(—)
- 性别
- All
入选标准
- •Aged 12 months and older and younger than 24 months
排除标准
- •1) Subjects with history of measles, mumps, or rubella infection
- •2) Subjects with history of measles, mumps, or rubella virus vaccination
研究者
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