Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,869
- 试验地点
- 4
- 主要终点
- Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
研究概览
简要总结
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
详细描述
Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to < 18 years. Subjects aged ≥ 2 months to < 12 months were randomized in a 2:1 ratio to receive IC51 (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to < 3 years and ≥ 12 years to < 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose < 3 years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator.
For subjects aged ≥ 3 years to < 12 years, a dose finding run-in phase was performed. A total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51, and the appropriate dose was determined based on an interim analysis. After this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of IC51 or HAVRIX®720.
Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to < 12 months; 125 children aged ≥ 12 months to < 3 years and 140 children ≥ 12 years to < 18 years. For the age group of ≥ 3 to < 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.
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
- None
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy children and adolescents aged > 2 months to < 18 years at the time of first vaccination.
- •Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
- •Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.
排除标准
- •Clinical manifestation of Japanese Encephalitis
- •History of Flavivirus vaccination (including any investigational vaccines)
- •History of vaccination with HAVRIX®720 and/or Prevnar®
- •History of immunodeficiency or immunosuppressive therapy
- •Known HIV, HBV or HCV infection
- •History of hypersensitivity reactions to other vaccines
- •Acute febrile infection at each visit during which the subject receives a vaccination
- •Active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.
结局指标
主要结局
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
时间窗: until Day 56
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged \< 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
次要结局
- Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies(Day 0, 56 and at Month 7)
- Rate of Subjects With Solicited Local and Systemic AEs(7 days post vaccination)
- Rate of Subjects With Abnormal Laboratory Parameters(Day 56 and Month 7)
- Seroconversion Rate (SCR) at Days 0, 56 and at Month 7(Days 0, 56 and at Month 7)
- Rate of Subjects With SAEs and Medically Attended AEs(up to Month 7)
- Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7(Day 56 and up to Month 7)