A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14
研究概览
简要总结
This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females of age ≥ 18 years.
- •Individuals who had given written consent.
- •Individuals in good health and available for all the visits scheduled in the study.
排除标准
- •Pregnancy or unwillingness to practice acceptable contraception.
- •A history of Rabies vaccination.
- •History of allergy to egg protein.
- •Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
- •A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
- •Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
- •Treatment with an anti-malarial drug, up to two months prior to the study.
- •Individuals who received any other vaccines within 28 days prior to enrollment.
- •Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- •Any planned surgery during the study period.
- •Subjects who have cancer disorders excluding nonmelanotic skin cancer.
研究组 & 干预措施
Group A-Zagreb
Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
干预措施: Purified Chick Embryo Cell Inactivated Rabies Vaccine (Biological)
Group B-Essen
Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14, and 28)
干预措施: Purified Chick Embryo Cell Inactivated Rabies Vaccine (Biological)
结局指标
主要结局
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14
时间窗: On Day 0 and Day 14
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule
次要结局
- Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations(Day 0, Day 7, Day 14 and Day 42)
- Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42(Study day 7, 14 and 42)
- Percentages of Subjects Reporting Adverse Events (AEs)(All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period)