A Multicentric open label phase-IV study to evaluate safety and tolerability of BE’s inactivated vero cell derived Japanese Encephalitis vaccine in ≥18 to ≤49 year old healthy adult subjects in a two dose schedule
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 8
- 主要终点
- 1.Solicited local and systemic adverse events (AEs)
研究概览
简要总结
This is a multicentre single arm unblinded post licensure study to evaluate safety and tolerability of BE’s inactivated vero cell derived Japanese Encephalitis vaccine in ≥18 to ≤49 year old healthy adult subjects.This vaccine to be administered intramuscularly in two dose schedule with an interval of 28 days between doses.A total of 432 adult subjects of either gender (greater than or equal to 18 years to less than or equal to 49 years) will be enrolled.No rotuine laboratory tests will be done during this study period.This Phase-IV study is expected to provide additional safety and tolerability data on BE’s Inactivated japanese Encephalitis vaccine to meet WHO prequalification requirements.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of either sex who are between ≥18 to ≤49 years at the time of 1st vaccination 2.Written informed consent obtained prior to screening from subjects or their legally acceptable representative 3.Free of clinically significant health problems as established by medical history and physical examination before entering into the study 4.Ability of the subject or his/her legally acceptable representative to understand and comply with the requirements of the protocol 5.Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
排除标准
- •1.Known exposure or history of any clinical manifestation of Japanese encephalitis, Dengue or yellow fever.
- •2.History of any previous vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever.
- •3.Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
- •4.Any family history of Immunodeficiency or autoimmune disease.
- •5.Administration of chronic (defined as more than 14 days) immune-suppressants or other immune-modifying drugs within 6 months of vaccination.
- •(For corticosteroids, this meant prednisone, or equivalent, ≥0.05 mg/kg/day.
- •Topical and inhaled steroids allowed).
- •6.History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission).
- •7.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
- •8.Subjects with history of uncontrolled diabetes, severe cardiopulmonary, hepatobiliary / renal disorders and or malignancy.
- •9.Any acute infection within two weeks prior to enrolment.
- •10.Drug addiction within 6 months prior to enrolment (including alcohol dependence, i.e. more than approx.
- •60 mL of alcohol per day, or conditions which might interfere with the study conduct).
- •11.Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects.
结局指标
主要结局
1.Solicited local and systemic adverse events (AEs)
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period of 28-days after each vaccination 4.During the entire course of the study period | 5.Until day 56 after the first vaccination | 6.During the study
2.Solicited and unsolicited local and systemic adverse events (AEs)captured through subject diary.
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period of 28-days after each vaccination 4.During the entire course of the study period | 5.Until day 56 after the first vaccination | 6.During the study
3.Solicited and unsolicited adverse events (AEs) 4.Proportion of subjects with serious and/or unexpected adverse events 5.Rate of SAEs and medically attended AEs
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period of 28-days after each vaccination 4.During the entire course of the study period | 5.Until day 56 after the first vaccination | 6.During the study
6.95% CI for proportion of adverse events reported
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period. | 3.During the subsequent follow up period of 28-days after each vaccination 4.During the entire course of the study period | 5.Until day 56 after the first vaccination | 6.During the study
次要结局
- Clinically significant changes in vital signs (Pulse, Oral body temperature, Blood Pressure and Respiratory rate)(From baseline to day 28 and day 56)