CTRI/2023/05/053120进行中（未招募）3 期
A Phase III, open label, prospective, multicenter, label expansion study to evaluate safety and immunogenicity of Inactivated Japanese Encephalitis Vaccine (JEEV™) in 49-70 years old adults and in the healthy 9-12 months old infants either alone or when co-administered with a licensed MMR vaccine at 9 months of age. - None
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria for Age Group – I:
- •1. Healthy infants of either gender between 9 months to 12 months of age at the time of enrolment:
- •o=9 - 12 months at the time of enrolment in sub-group-1,
- •o=9 months (+15 days time window) at the time of enrolment in sub-group-2 and sub group-3
- •2.Residence in the study area.
- •3. Parent or guardian willing to provide written informed consent.
- •4. Generally healthy and free of obvious health problems as established by medical history, physical examination, and clinical judgment by the investigator.
- •5. Parent or guardian is willing to attend all planned study visits and allow home visits and phone contacts, as required by the protocol.
- •Inclusion Criteria for Age Group - II:
- •1. Male or female subjects = 49 to 70 years of age at the time of 1st vaccination of good general health status including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, cardiovascular disease or non-insulin dependent diabetes mellitus.
- •2. Written informed consent obtained from the subject prior to any study related procedures
- •3. White blood cells =2,500/mm3 and <11,000/mm3 at Visit 1 Screening & Enrollment Visit)
- •4. Absolute neutrophil count within normal limits at Visit 1 (Screening & Enrollment Visit)
- •5. Platelets within normal limits at Visit 1 (Screening & Enrollment Visit)
排除标准
- •Exclusion Criteria for Age Group – I:
- •1. Previous receipt of any measles-mumps-rubella containing vaccine (Exclusion for Sub Group II & III only under Group-I).
- •2. Previous receipt of any Japanese encephalitis vaccine.
- •3.History of measles, mumps, rubella, or Japanese encephalitis infection.
- •4.Administration of any other vaccine within 28 days prior to administration of a study vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI vaccines or oral polio vaccine during the 28 days after study vaccination.
- •5. Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the study period.
- •Exclusion Criteria for Age Group – II:
- •1. History of clinical manifestation of any flavivirus infection (Yellow Fever, Dengue Fever, JE, Tick Borne Encephalitis (TBE) and West e Fever/Neuroinvasive Disease (Neuroinvasive disease is defined as organism infecting or capable of infecting the nervous system and especially the central nervous system);
- •2. Vaccination against JE, Yellow fever, Dengue Fever or West e Fever at any time prior or during the study;
- •3. Vaccination against Tick Borne Encephalitis (TBE) within 30 days prior to first dose of JEEV vaccination at Visit 1 (Day 0);
- •4.Use of any other investigational or non-registered medicinal product within 30 days prior to JEEV vaccination at Visit 1 (Day 0) and throughout the entire study period;
- •5. Known history of Infection with the human immunodeficiency virus (HIV), Hepatitis B virus (HBV, Hepatitis B surface antigen [HBsAg]) or Hepatitis C virus (HCV).
- •5. Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to first JEEV vaccination at Visit 1 (Day 0) and during study period;
- •6. History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded;
- •7. Acute febrile infections or exacerbation of chronic infection on the day of JEEV vaccination (Day 0 and Day 28);
研究者
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