CTRI/2012/08/002909已完成4 期
A Multicentric open label phase-IV study to evaluate safety and tolerability of BEâ??s inactivated vero cell derived Japanese Encephalitis vaccine in â?¥18 to â?¤49 year old healthy adult subjects in a two dose schedule - None
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 432
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
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.
- •12.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
研究者
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