CTRI/2018/07/014919招募中2 期
A Phase II/III, Multicenter, Randomized, Single Blind Clinical Study to Compare the Immunogenicity and Safety of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd with Tetanus Vaccine (Adsorbed) of M/S Serum Institute of India Ltd In Healthy Subjects
Seasons Biologicals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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. Healthy subjects of either gender, between 10-45 years of age who give written informed consent prior to the study entry. Children and adolescent (between the age group of 10 -17) having signed the assent consent form
- •2. Subject with clean minor wound(s) who had been warranted for receiving Tetanus Toxoid (Adsorbed)
- •3. Willingness to adhere to the study requirements
- •4. Subjects with good health as determined by:
- •Medical history, Physical examination, Clinical judgment of the investigator and Clinical laboratory examination (subjects with clinically acceptable range during baseline screening)
排除标准
- •1. Administration of immunoglobulin or blood or any blood products since birth.
- •2. Use of any investigational or un-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the study vaccination.
- •3. Subjects who had received any vaccines 6 months prior to study entry
- •4. Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years
- •5. Previous evidence of Tetanus.
- •6. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics
- •7. Major congenital or hereditary immunodeficiency.
- •8. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days or planned administration during the study period.
- •9. Subjects with febrile illness (temperature > 38 degree centigrade) at the time of enrollment
- •10. Subjects who have received cytotoxic agents or radiotherapy within last month
- •11. Evidence of disease or history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
- •12. Subjects having history or presence of drug abuse or alcoholism within one year prior to study entry
- •13. Subjects having history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products
- •14. Subjects having difficulty in donating blood and Subjects who have donated blood within the past 3 months
- •15. Pregnant and nourishing women
- •16. Subjects who are planning to leave the area of the study site before the end of the study period.
- •17. Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study
研究者
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