A Phase IV Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Japanese Encephalitis Vaccine in healthy volunteers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- 1) To evaluate the immunogenicity of the Test vaccine in terms of Seroconversion, Seroprotection and Geometric Mean Titers (GMTs) of JEV neutralizing antibody four weeks post vaccination in Group I and Group II.
研究概览
简要总结
In this study, we are comparing test(vaccine group) Vs. Control (non-vaccine group) to study seroprevalence and immunogenicityin both endemic and non-endemic zones aged 1 to 65 years. The rationale forincluding a control arm is to assess and compare seroprevalence rates for JEbetween both groups. This would provide the investigators with increasedknowledge of how JENVAC can produce robust immune responses.
Controlvaccine administered will be Typbar-TCV (Typhoid conjugate vaccine) from 9months to 45 years or seasonal flu vaccine for ages above 45 years. Both theIndian Academy of Pediatricians and WHO have recommended Typbar-TCV to beadministered in typhoid endemic countries with a single dose. Since bothvaccines are not available in the National Immunization Program, potentialcontrol participants in this study will receive the added benefit of protectionfrom both Typhoid Fever and Seasonal Influenza. Due to the study beingconducted in JE endemic settings, a month after receipt of these controlvaccines, participants will receive a dose of JENVAC which will offerprotection to JE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of age 1 to ≤65 years without significant medical history or abnormal clinical findings.
- •2.Subject or Subject’s Legally Acceptable Representative (LAR) who has been explained about all risks and benefits of the study and is willing to provide written informed consent.
- •3.Agree to be available for all study related visits and procedures throughout the entire duration of the study.
- •4.Individuals who are in good health as determined by the outcome of medical history, physical examination and based on the clinical judgement of the Principal Investigator.
排除标准
- •1.Subjects with age less than 1 year and more than 65 years.
- •2.Fever of any origin of duration more than 3 days within one month prior to screening or on the day of screening.
- •3.History of malaise, head ache, anorexia at the time of screening or of the vaccine under study.
- •4.Past history of JE vaccination.
- •5.Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, hematological or immune disorders.
- •6.Any confirmed or suspected immunosuppressive or Immunodeficient condition.
- •7.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for JE or other vaccine in the past 2months.
- •8.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
- •9.Previous history of hypersensitive reaction to vaccine or vaccine component.
- •10.Women who are pregnant or breast-feeding.
- •11.Married or sexually active participants who are not willing to follow effective birth control methods during the treatment period.
- •12.Individuals participating in any other clinical trial within one month prior to study participation or intent to participate in any other clinical trial during the conduct of the study.
结局指标
主要结局
1) To evaluate the immunogenicity of the Test vaccine in terms of Seroconversion, Seroprotection and Geometric Mean Titers (GMTs) of JEV neutralizing antibody four weeks post vaccination in Group I and Group II.
时间窗: 1) day 0 and 28
次要结局
- 1) To assess and evaluate the safety of the test vaccine in Group I and Group II.(1) day 0 and 28)