Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
研究概览
简要总结
This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period.
Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
- •Aged ≥ 9 months to < 10 years
- •In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
- •Subject had to be available for the study duration for the study duration, including all planned follow-up visits.
排除标准
- •A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
- •Demonstration of parasitemia on malaria blood smear at Screening.
- •History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
- •hypersensitivity to thimerosal or gelatin
- •Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,
- •Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system,
- •Have a history of severe reaction to other vaccines,
- •Have a chronic condition requiring medication,
- •Intend to travel out of the area during the study period,
- •Have spent at least 4 weeks in a JE-endemic region,
- •Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening,
- •Exhibit signs of secondary or tertiary malnutrition,
- •Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,
- •Have malaria infection, or who have a fever within 3 days before vaccination.
- •Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled.
- •Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
时间窗: Day 14 up to Day 42 Post-vaccination
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
时间窗: Day 14 up to Day 42 Post-vaccination
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
时间窗: Day 42 Post-vaccination
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
时间窗: Day 42 Post Dose 1
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
次要结局
- Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine(Day 42 Post Dose 1)
- Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine(Day 42 Post-vaccination)