NCT00596271已完成3 期
Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-blind Randomized, Controlled Phase 3 Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
研究概览
简要总结
The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
详细描述
This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
192 subjects will be enrolled at 2 sites in Europe.
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
- Single (Participant)
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
- •At least 18 years of age
- •In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
- •Written informed consent obtained prior to study entry
排除标准
- •History of clinical manifestation of any flavivirus infection
- •History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- •History of any previous Hepatitis A vaccination and infection
- •Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- •Planned administration of another vaccine during the study period
- •Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- •A family history of congenital or hereditary immunodeficiency
- •History of autoimmune disease
- •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- •Any acute infections within 4 weeks prior to enrollment
- •Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
结局指标
主要结局
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
时间窗: Day 56
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
GMT for Hepatitis A Virus (HAV) Antibody at Day 28
时间窗: Day 28
次要结局
- Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28(day 28 and 56)
- GMT and SCR for PRNT at Day 28 and HAV at Day 56(day 28 and 56)
- Safety(until 6 month after last vaccination)
研究者
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