An open-label, single-treatment, single-period, single dose, clinical phase 1 study to assess the safety and tolerability of Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (adsorbed) I.P. 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 Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd., India given intramuscularly in healthy adult male human subjects.
研究概览
简要总结
The objective of thestudy is to assess the safety and tolerability of Diphtheria, Tetanus,Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugatevaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd., India givenintramuscularly in healthy adult male human subjects.
This is an open-label,single-treatment, single-period, single dose, phase 1 vaccine 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 after previous dose of any Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccines or to any other component of the vaccine.
- •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 Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus type B conjugate vaccine (Adsorbed) I.P. of M/s Cadila Healthcare Ltd., India given intramuscularly in healthy adult male human subjects.
时间窗: Vital signs i.e Oral temperature,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)