A Phase I Open Label Study to Evaluate the Safety of Tetanus Vaccine (Adsorbed) in Healthy Indian Adults

Seasons Biologicals Pvt Ltd0 个研究点目标入组 33 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Healthy Adults of 18-45 years of age who give written informed consent prior to the study entry
•Willingness to adhere to the study requirements
•Subjects with good health as determined by:
•oMedical history
•oPhysical examination
•oClinical judgment of the investigator
•oClinical laboratory examination (subjects with clinically acceptable range during baseline screening)

•Administration of immunoglobulin or any blood products since birth.
•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.
•Subjects who had received any vaccines 6 months prior to study entry
•Previous evidence of Tetanus.
•History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics
•Major congenital or hereditary immunodeficiency.
•Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days.
•Subjects who have received cytotoxic agents or radiotherapy within last month
•Evidence of disease or fever, 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
•Subjects having history or presence of drug abuse or alcoholism within 1 year prior to study entry
•Subjects having history or presence of significant smoking (more than 10 cigarettes per day) or consumption of
•tobacco products
•Subjects having difficulty in donating blood and Subjects who have donated blood within the past 3 months
•Pregnant and nourishing women
•Subjects who are planning to leave the area of the study site before the end of the study period.

发起方

Seasons Biologicals Pvt Ltd