An open-label, single treatment, single period, single dose, clinical phase 1 study to assess the safety and tolerability of Measles, Mumps, Rubella & Varicella vaccine (live attenuated, freeze dried) of M/s Cadila Healthcare Ltd., India in healthy, adult, male, human subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of Measles, Mumps, Rubella &Varicella Vaccine (Live Attenuated, Freeze Dried) of M/s. Cadila Healthcare Ltd., India given subcutaneously in healthy adult male human subjects.
研究概览
简要总结
The objective of the study is to assess the safetyand tolerability of Measles,Mumps, Rubella &Varicella Vaccine (Live Attenuated, Freeze Dried) of M/s. Cadila Healthcare Ltd., India givensubcutaneously in healthy adult male human subjects.
This is an open-label, single-treatment, single-period, single dose, phase 1clinical study in healthy, adult, male, human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •â€¢Male subjects aged between 18 and 45 years (both inclusive).
- •â€¢Subjects’ 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, egg proteins, neomycin, gelatin or gelatin containing product.
- •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 product.
- •â€¢Difficulty with donating blood.
- •â€¢Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg. •Pulse less than 60/minute or more than 110/minute.
- •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.
结局指标
主要结局
To assess the safety and tolerability of Measles, Mumps, Rubella &Varicella Vaccine (Live Attenuated, Freeze Dried) of M/s. Cadila Healthcare Ltd., India given subcutaneously in healthy adult male human subjects.
时间窗: Vital signs i.e Oral temerature,sitting blood pressure and radial pulse:check-in, prior to administration of dose, 1, 2, 6, and 12 hours after administration of dose, at checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42. | Respiratory Rate and Clinical examination: check-in, checkout (Day 01), Day 3,Day 7, Day 14, Day 21 and Day 42. | ECG:-screening. | Lab assessments:screening. Hematology,LFT and RFT tests on Day 21. | Check-in:Urine test for drug of abuse and alcohol breath test.
次要结局
- NA(NA)