Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2,004
- 试验地点
- 22
- 主要终点
- Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
研究概览
简要总结
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained from the subject.
- •Aged 18 years or above at screening.
- •In good general health
- •Subject available for the study duration
- •For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.
排除标准
- •A history of vaccination against or infection with JE.
- •Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
- •History of thymoma, thymic surgery (removal) or myasthenia gravis.
- •Clinically significant abnormalities on laboratory assessment
- •Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
- •Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day
- •Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day
- •Physical examination indicating any clinically significant medical condition.
- •Oral temperature >38°C (100.4°F) or acute illness within 3 days prior to inoculation.
- •Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day
- •Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
- •Lactation or intended pregnancy in female subjects.
- •Excessive alcohol consumption, drug abuse, significant psychiatric illness.
- •A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
- •Participation in another clinical study within 30 days of the screening visit for this study.
- •Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
- •Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.
结局指标
主要结局
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
时间窗: Day 0 up to 30 days post-vaccination
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
时间窗: Day 0 up to 30 days post-vaccination
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
次要结局
未报告次要终点