A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 820
- 试验地点
- 10
- 主要终点
- Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
研究概览
简要总结
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18 or above
- •Subjects in good general health.
- •Females must have negative pregnancy test and be using adequate form of contraception
排除标准
- •History of vaccination/infection with JE or Yellow fever or other flaviviruses
- •History of residence/travel to flavivirus endemic regions
- •History of anaphylaxis/serious adverse reactions
- •Administration of vaccine within 30 days of study or during treatment period
- •Clinically significant physical exam/medical history/lab abnormalities
- •Pregnancy
- •Excessive alcohol/drug abuse
- •Hypersensitivity to constituents of JE-VAX®
- •Blood transfusion/treatment with blood product within 6months of study and during study treatment period
- •Known/suspected immunodeficiency
- •Compromised blood brain barrier
- •Employees of Clinical Research Organization (CRO)/study site staff
- •Any other condition which would exclude subject.
结局指标
主要结局
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
时间窗: Up to Day 60 post-first vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
时间窗: Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
次要结局
- Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination(Up to Day 60 post-first vaccination)
- Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination(Day 60 post-first vaccination)