Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
研究概览
简要总结
This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.
详细描述
The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 1 to <5 years on the day of inclusion
- •History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
- •In good general health at the time of inclusion
- •Provision of informed consent by the parent(s) or legal guardian(s)
排除标准
- •Receipt of blood or blood products in the past 3 months
- •Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
- •Previous receipt of 2 doses of any vaccine against JE virus
- •Known hypersensitivity to any of the vaccine components
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
结局指标
主要结局
Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
时间窗: Day 0 (Baseline) and Day 28 (post-vaccination)
Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
次要结局
- Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination(Day 0 (Baseline) and Day 28 (post-vaccination))
- Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™(Up to 28 days post booster vaccination)
研究者
Kulkanya Chokephaibulkit
Professor
Siriraj Hospital