NCT00825305已完成3 期
A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 825 人开始时间: 2008年11月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 825
- 试验地点
- 1
- 主要终点
- Rabies Virus Neutralizing Antibody Concentrations on Day 14.
研究概览
简要总结
This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects 18-50 years of age who:
- •are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
- •volunteer for the simulated post-exposure vaccination courses and blood draws;
- •have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
- •are available for all the visits scheduled in the study.
排除标准
- •Subjects with the below criteria were excluded:
- •pregnancy or unwillingness to practice acceptable contraception during participation in the study;
- •a history of rabies immunization;
- •a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
- •fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
- •treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;
- •administration of any vaccine within the past 14 days before enrolment;
- •known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
- •history of allergy to egg protein;
- •known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;
- •treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;
- •mental condition rendering the subject unable to understand the nature, scope and consequences of the study;
- •participation in any other investigational trial within the past 3 months before enrolment;
- •planned surgery during the study period;
- •intention to leave the area of the study site before the end of study period;
- •any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
结局指标
主要结局
Rabies Virus Neutralizing Antibody Concentrations on Day 14.
时间窗: 14 days
Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination
时间窗: 7 days after each vaccination
Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.
次要结局
- Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.(7 days and 42 days)
- Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.(7 days, 14 days and 42 days)
研究者
研究点 (1)
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