CTRI/2014/01/004340已完成1 期
AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, PHASE 1CLINICAL STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF HAEMOPHILUSTYPE B CONJUGATE VACCINE OF M/s CADILA HEALTHCARE LTD., INDIA IN HEALTHY,ADULT, MALE, HUMAN SUBJECTS UNDER FASTING CONDITION - Not applicable
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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
- •Â· Male subjects aged between 18 and 45 years (including both).
- •Â· Subjectsâ?? weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of
- •India for non-medical cases.
- •Â· Ability to communicate effectively with study personnel.
- •Â· Willingness to adhere to the protocol requirements.
- •Â· Be able to give consent for participation in the trial.
- •Â· Normal health as determined by personal medical history, clinical examination and laboratory
- •examinations data during screening (within the clinically acceptable range).
排除标准
- •Â· History of anaphylaxis or serious reactions to vaccines, aluminum or aluminum containing
- •Â· Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant
- •medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •Â· 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.
- •Â· Subjects who have received immunoglobulins parenterally during the preceding 3 months.
- •Â· Subjects who have received any vaccine in the preceding 6 months.
- •Â· History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
- •immunological, dermatological, neurological, psychiatric disease or any other body system
- •involvement.
- •Â· History or presence of significant alcoholism or drug abuse within the past one-year.
- •Â· History or presence of significant smoking (more than 10 cigarettes per day) or consumption of
- •tobacco products.
- •Â· Difficulty with donating blood.
- •Â· Blood pressure less than 100/60 mm Hg or more than 140/90 mm Hg.
- •Â· Pulse less than 60/minute or more than 110/minute.
- •Â· Febrile.
- •Â· Any ECG abnormalities.
- •Â· Any clinically significant abnormal laboratory values during screening.
- •Â· Any clinically significant chest X-Ray findings during screening.
- •Â· Major illness during 3 months before the screening period
- •Â· Subjects who have participated in drug research studies within past 3 months.
- •Â· Subjects who have donated one unit (350ml) of blood in the past 3 months.
- •Also subjects will be assessed for alcohol and drug of abuse consumption at the time of check in
- •during the study. Subjects who are found positive in alcohol breathe test and urine test for drug of abuse, will not be enrolled in the study.
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