A multicentric, single blind, parallel, randomized phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Toxoid vaccine BETT administered to healthy Indian adults of either gender aged between 18-50 years in comparison with the marketed ShanTTÂ® vaccine - A non-inferiority study. - None

Biological E Limited0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Written informed consent obtained from the subject or his/her legally acceptable representative;
•2) Healthy Indian subjects of either gender aged between 18-50 yrs of age;
•3) Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >39.5 degrees);
•4) History of previous immunisation with TT;
•5) Subjects without any history of contagious diseases.

•1) Subjects with acute disease at the time of enrolment, defined as presence of a moderate or severe illness;
•2) Clinical or serological findings suggestive of any contagious disease at the time of screening;
•3) Known case of hypersensitivity to any of the components of TT vaccine;
•4) Known history of any Serious Adverse Reaction (SAR) with previous TT immunizations in the individual to be immunized;
•5) Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.

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