CTRI/2017/07/009034已完成1 期
A phase I, prospective, open label clinical study to assess the safety and tolerability of DTaP-IPV+Hib vaccine manufactured by Serum Institute of India Pvt. Ltd. in healthy adult volunteers
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 DTaP IPV Hib vaccine
研究概览
简要总结
The study is a phase I, prospective and open label clinical trial to assess safety and tolerability of SIIPL‟s DTaPIPV+Hib vaccine in 24 healthy adult volunteers aged 18-45 years. Active follow up for vaccine reactogenicity over the 7 day period after vaccination will be conducted in all subjects. In addition, all the subjects will be followed up for unsolicited AEs and SAEs over the period between enrollment and 30 days after vaccination.
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
- All
入选标准
- •Healthy adult human subjects between 18 and 45 years of age (both inclusive) .
- •Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2 with minimum of 50 kg weight.
- •Healthy subjects as established by personal medical history, physical examination, laboratory investigation during screening and as per the clinical judgment of the Investigator.
- •Sexually active participants to be using an effective method of contraception (i.e. intrauterine device or hormonal contraception or condom, diaphragm, cervical cap).
- •Subject‟s willingness and ability to comply with the requirements of the protocol.
- •Subject willing to sign a written informed consent.
排除标准
- •History of any allergic diseases or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- •History of anaphylactic shock.
- •History of previous vaccination against diphtheria, tetanus, pertussis, polio or Hib with either the trial vaccine or another vaccine (except Tetanusprone wound management for adults) in the past 5 years.
- •History of diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type B infection (confirmed either clinically, serologically or microbiologically).
- •History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
- •History of any cancer, leukemia, HIV infection, organ transplant or any other immune system disease.
- •History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •Ingestion or Use of any medication (including herbal remedies) at any time in 14 days or immune-modifying drugs in last 3 months prior to IP administration or planned at any time during the study.
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •Smokers, who smoke 10 or more than 10 cigarettes/beedis per day or inability to abstain from smoking during the study.
- •History of significant alcoholism in the past one year.
- •The presence of clinically significant abnormal laboratory values during screening.
- •Abnormal ECG and chest X-ray.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
- •History or presence of psychiatric disorder
- •A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •A positive test result for HIV antibody.
- •Female participant who is pregnant or breast-feeding, or wanting to fall pregnant during trial participation.
- •Investigator, site personnel directly affiliated with this study and their immediate families.
- •Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- •Acute illness (moderate or severe) and/or fever (oral temperature ≥38°C) at the time of vaccination or during the 7 days prior to the vaccination.
- •History of receipt a blood transfusion or other blood products in the year prior to screening.
- •Use of any investigational or non-registered drug within 30 days preceding the study vaccine administration, or planned use during the study period.
- •History of administration of any vaccine within 30 days prior to administration of study vaccine or planned during the course of study participation.
- •Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
- •Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study.
结局指标
主要结局
To assess the safety and tolerability of DTaP IPV Hib vaccine
时间窗: To assess the safety and tolerability of DTaP IPV Hib vaccine, on day 7 and 30 post vaccination
次要结局
- Not applicable(Not Applicable)
研究者
研究点 (1)
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