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
研究组 & 干预措施
IC51
In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24.
干预措施: IC51 (Biological)
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
- SCR 1 Month After the Booster Doses(1 month)
- Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination(24 months)
- 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)