EUCTR2010-018630-52-AT进行中（未招募）不适用
AN OPEN-LABEL, UNCONTROLLED PHASE 4 STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS (JE) VACCINE IXIARO® (IC51) IN AN ELDERLY POPULATION - IC51-315
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects = 65 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-insulindependent diabetes mellitus
- •2. Weight: = 45.5 kg and = 150 kg at Visit 0 (Screening Visit)
- •3. White blood cells =2,500/mm3 and <11,000/mm3 at Visit 0
- •4. Absolute neutrophil count within normal limits at Visit 0
- •5. Platelets within normal limits at Visit 0
- •6. Written informed consent obtained from the subject prior to any study-related
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of clinical manifestation of any flavivirus infection (Yellow Fever, Dengue
- •Fever, JE, Tick Borne Encephalitis (TBE) and West e Fever/Neuroinvasive Disease)
- •2. Vaccination against JE (including study participation in any previous or current
- •IC51/IXIARO® clinical study), Yellow fever, Dengue Fever or West e Fever at any
- •time prior or during the study
- •3. Vaccination against TBE within 30 days prior to first IXIARO® vaccination at Visit 1
- •(Day 0) and until Visit 3 (Day 70)
- •4. Use of any other investigational or non-registered medicinal product within 30 days prior to IXIARO® vaccination at Visit 1 (Day 0) and throughout the entire study period
- •5. Immunodeficiency including status post-organ-transplantation or immunosuppressive therapy, and a family history of congenital or hereditary
- •immunodeficiency
- •6. Infection with the human immunodeficiency virus (HIV, a negative test result within
- •30 days before screening is acceptable), Hepatitis B virus (HBV, Hepatitis B surface
- •antigen [HBsAg]) or Hepatitis C virus (HCV)
- •7. Administration of chronic (defined as longer than 14 days) immunosuppressants or
- •other immune-modifying drugs within 30 days prior to IXIARO® vaccination at
- •Visit 1 (Day 0) and during the study until Visit 3 (Day 70). (For corticosteroids this
- •means prednisone or equivalent = 0.05 mg/kg/day; topical and inhaled steroids are
- •8. Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to
- •first IXIARO® vaccination at Visit 1 (Day 0) and until Visit 3 (Day 70)
- •9. History of autoimmune disease, including Type I Diabetes mellitus. Subjects with
- •vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
- •10. Acute febrile infections or exacerbation of chronic infection on the day of IXIARO®
- •vaccination (Day 0 and Day 28)
- •11. Clinically significant hematological, renal, hepatic, pulmonary, central nervous,
- •cardiovascular or gastrointestinal disorders, which are not adequately controlled by
- •medical treatment within the last 12 weeks before IXIARO® vaccination at Visit 1
- •(Day 0) as judged by the site`s Principal Investigator
- •14 Clinically significant mental disorder not adequately controlled by medical treatment
- •15 History of Guillain-Barré-Syndrome (GBS).
- •16 History of severe hypersensitivity reactions, in particular to a component of the
- •IXIARO® vaccine (e.g. protamine sulfate), anaphylaxis or severe cases of atopy
- •requiring emergency treatment or hospital admission
研究者
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