A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 661
- 试验地点
- 6
- 主要终点
- Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
研究概览
简要总结
Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between 18 and 65 years of age (inclusive).
- •Subjects who have given written consent.
- •Individuals in good health as per investigator judgement.
排除标准
- •If female, pregnancy or unwillingness to practice acceptable contraception.
- •If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
- •Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
- •Unable to comprehend and to follow all required study procedures for the whole period of the study.
- •Participating in any other clinical trial 30 days prior to first study visit.
- •History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.
- •Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day
- •Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines.
- •Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- •Individuals who are part of study personnel or close family members conducting this study.
- •Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
- •Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.
结局指标
主要结局
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
时间窗: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
时间窗: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)
Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
次要结局
- Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination(Day 15 and day 36 (28 after last active vaccination))
- Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10(Days 1, 15, 22, 36, 57, 91, 181 and 366)
- Kinetics of Rabies Immune Response Measured as the RVNA GMCs(Day 1, 8, 15, 36, 57, 91, 181, and 366)
- PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination(Day 57 (28 days after last active vaccination))
- Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination(Day 36 and day 57 (28 days after last active vaccination))
- Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL(Day 1, 8, 15, 36, 57, 91, 181 and Day 366)
- Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57(Day 1 through Day 57)
- Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination(Day 1 through day 7 after each vaccination (on day 1, 8 and 29))
- Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection(Day 1 through day 7 after each injection (day 1, 4, 8 and 29))
- Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination(Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29))
- RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination(Day 57 (28 days after last active vaccination))
- Kinetics of JE Immune Response Measured as PRNT50 GMTs(Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule))
- Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination(Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29))