CTRI/2020/01/022797进行中（未招募）1 期
AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, CLINICAL PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF INACTIVATED HEPATITIS A VACCINE (ADSORBED) I.P. OF M/s CADILA HEALTHCARE LTD., INDIA IN HEALTHY, ADULT HUMAN SUBJECTS - HAV 1001
试验速览
- 阶段
- 1 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
- •1)Male and non-pregnant, non-lactating female subjects aged between 18 and 45 years (both inclusive).
- •2)Body weight > 50 kg for male and >45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive).
- •3)Ability to communicate effectively with study personnel.
- •4)Willingness to adhere to the protocol requirements.
- •5)Be able to give consent for participation in the trial.
- •6)Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening (within the clinically acceptable range) during the study.
排除标准
- •1) History of anaphylaxis or serious reactions to any vaccines.
- •2) Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •3) Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive.
- •4) Subjects who have received immunoglobulins parenterally during the preceding 3 months.
- •5) Subjects who have received any vaccine in the preceding 6 months.
- •6) History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or gynecological any other body system involvement.
- •7) History or presence of significant alcoholism or drug abuse within the past one-year.
- •8) History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.
- •9) Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
- •10) Pulse less than 60/minute or more than 100/minute.
- •11) History of fever in last 2 weeks
- •12) Any clinically significant ECG abnormalities.
- •13) Any clinically significant abnormal laboratory values during screening.
- •14) Any clinically significant chest X-Ray findings during screening.
- •15) Major illness during 3 months before the screening period.
- •16) Subjects who have participated in drug research studies within past 3 months.
研究者
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