CTRI/2017/05/008537已完成1 期
An open-label, single-treatment, single-period, single dose, clinical phase 1 study to assess the safety and tolerability of Bivalent Human Papillomavirus (Types 16 L1 & 18 L1) Vaccine of M/s Cadila Healthcare Ltd., India in healthy, adult, female, human subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
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)Female subjects aged between 18 and 45 years (both inclusive).
- •2)Subjectsâ?? weight within +/-15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
- •3)No history of pregnancy or lactation in the past 3 months.
- •4)Fertile female volunteers protected against pregnancy by adequate long-term anti-fertility measures (oral or injectable hormonal contraceptives, Intrauterine contraceptive device, or surgical sterilization along with barrier method).
- •5)Ability to communicate effectively with study personnel.
- •6)Willingness to adhere to the protocol requirements.
- •7)Be able to give consent for participation in the trial.
- •8)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
- •1)History of pregnancy or lactation in the past 3 months.
- •2)Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures (oral or injectable hormonal contraceptives, Intrauterine contraceptive device, or surgical sterilization along with barrier method).
- •3)History of less than 1 year of menopause and not using adequate long-term anti-fertility measures.
- •4)Using Hormone replacement therapy.
- •5)Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial.
- •6)Positive urine pregnancy testor serum β-hCG level on the day of screening or on the day of check-in.
- •7)History of anaphylaxis or serious reactions to vaccines, egg proteins, neomycin, gelatin or gelatin containing product.
- •8)Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •9)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.
- •10)Subjects who have received immunoglobulinsparenterally during the preceding 3 months.
- •11)Subjects who have received any vaccine in the preceding 6 months.
- •12)History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
- •13)History or presence of significant alcoholism or drug abuse within the past one-year.
- •14)History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.
- •15)Difficulty with donating blood.
- •16)Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
- •17)Pulse less than 60/minute or more than 110/minute.
- •18)Febrile.
- •19)Any ECG abnormalities.
- •20)Any clinically significant abnormal laboratory values during screening.
- •21)Any clinically significant chest X-Ray findings during screening.
- •22)Major illness during 3 months before the screening period.
- •23)Subjects who have participated in drug research studies within past 3 months.
- •24)Subjects who have donated one unit (350ml) of blood in the past 3 months.
研究者
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