Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 639
- 主要终点
- GMT for Anti-JEV Neutralizing Antibody
研究概览
简要总结
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
详细描述
This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test
排除标准
- •History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence
研究组 & 干预措施
IC51 Group C
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
干预措施: IC51 (Biological)
IC51 Group B
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
干预措施: IC51 (Biological)
IC51 Group A
IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
干预措施: IC51 (Biological)
结局指标
主要结局
GMT for Anti-JEV Neutralizing Antibody
时间窗: day 56
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
次要结局
- SCR for Anti-JEC Neutralizing Antibody Titer(day 56)
- Safety(study duration)