Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 349
- 主要终点
- Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
研究概览
简要总结
The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose
详细描述
This is an open label, non-randomized multi-center phase 3 follow-up study. All volunteers having completed trial IC51-304 (NCT00595790) will be enrolled into this trial at 2 sites
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Written informed consent obtained prior to study entry
- •Subjects correctly included in and having completed study IC51-304 according to the protocol.
排除标准
- •Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
- •Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- •Pregnancy, lactation or unreliable contraception in female subjects
结局指标
主要结局
Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
时间窗: - 24 months
Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: * pos. (positive) (persistent): Subjects * with a non-missing, pos. seroconversion at D56 (Study IC51-304) and * without booster at M11 or M23 and * with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and * with non-missing, SP pos. PRNT50 at M24 * neg. (negative) (non-persistent): Subjects with * missing or neg. seroconversion at D56 (Study IC51-304) or * booster at M11 or at M23, or * non-missing, SP neg. PRNT50 at M6 or M12 or * missing PRNT50 at both M6 and M12 or * missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24
次要结局
- Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination(24 months)
- SCR 1 Month After the Booster Doses(1 month)
- GMT 1month After Booster Doses(1 month)
- Safety Profile of IC51(study duration)
- SPR 24 Months After the Primary Vaccination (Observed)(24 months)
- Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination(- 24 months)