A Multi-center, Open, phase4 Study to Assess the Long-term Immunogenicity and Safety of Fourth Administration of BR JEV and to Investigate on Vaccine Interchangeability in Children Aged 6 Years Who Received 3 Doses With ENCEVAC or JEV-GCC
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 9
- 主要终点
- To assess the seroconversion rates before and after the fourth dose of JEV
研究概览
简要总结
A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in Korean children aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC® inj.
详细描述
This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of JEV are the target population in this study. The purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but manufactured by a different manufacturer.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
- •Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.
- •Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.
- •Male and female children who are identified to be healthy based on physical examination and medical history.
排除标准
- •Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.
- •Children who have moderate or severe acute disease (regardless of fever).
- •Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.
- •Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.
- •Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after vaccination.
- •Children who have shown anaphylactic reaction to the investigational products administered in the KD287-BR-CT-301study or who are likely to be allergic to the ingredients of the investigational product.
- •Children who have been diagnosed with immunodeficiency such as acquired immune deficiency or who have family history of immunodeficiency.
- •Children who have received other vaccines within 28 days before booster dosing of JEV (vaccines to be administered according to the national vaccination program.
- •Children who have received immunosuppressive thera-py within 28 days before booster dosing of JEV.
- •There is a possibility that immune globulin preparations has not been excreted enough on the day of booster dosing of JEV if children have received such a product.
- •Children who are currently participating or planning to participate in other clinical stud-ies during the study period.
- •Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.
结局指标
主要结局
To assess the seroconversion rates before and after the fourth dose of JEV
时间窗: Day 28 (28 days after booster dose)]
次要结局
- To assess the seropositive rates before and after the fourth dose of JEV(Day 28 (28 days after booster dose)])
- To assess the percentage of subjects who develop neutralizing antibody titers(Day 28 (28 days after booster dose))
- To assess the geometric mean titer (GMT) before and after the fourth dose of JEV(Day 28 (28 days after booster dose)])
- To assess the percentage of subjects in their neutralizing anti-body titers(Day 28 (28 days after booster dose))