A Multicentre, Open label, randomised, phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Diphtheria (Td) vaccine (adsorbed) administered to healthy Indian children â?¥7 years, Adolescents and Adults who received primary immunisation as compared with a marketed Diphtheria and Tetanus (Td) vaccine - None

Biological E Limited0 个研究点目标入组 270 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 from the subject or subjectâ??s parent/guardian or subjectâ??s legally acceptable representative
•2.Informed assent directly from the child/adolescent aged between >=7 to <18 years in addition to consent from subject or his/her LAR, except when the subject is incapable of providing it because of immaturity or cognitive abilities as judged by the Investigator.
•3.Healthy Indian subjects of either gender between >=7 to <18 years in child/adolescent age subset and >=18 years of age in adult age subset at the time of vaccination.
•4.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >103.5Â°F [ >39.5Â°C]).
•5.History of previous primary immunisation with DTP vaccine at childhood.
•6.Willingness of subject or subjectâ??s parent/guardian or their legally acceptable representative not to participate in any other clinical trial during the course of study.
•7.Subject or subjectâ??s parent/guardian or subjectâ??s legally acceptable representative willing to comply with the protocol requirements.
•8.Subjects who were not receiving any immunosuppressive therapy.
•9.Subjects without contraindications or precautionary circumstances.

•1.History of Tetanus (TT) or Tetanus with reduced diphtheria (Td) booster vaccination within last 5 years.
•2.Subjects with acute disease at the time of enrolment, defined as â??presence of a moderate or severe illnessâ??.
•3.Life-threatening or serious cardiac, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematologic or immunologic disorder.
•4.Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
•5.Pregnant women and women with childbearing potential not following proven contraceptive methods.
•6.Subjects on immunosuppressive or immunostimulant therapy.
•7.Any confirmed or suspected immunosuppressive or immunodeficient condition.
•8.Known case of hypersensitivity to any of the components of Td vaccine.
•9.Known history of any serious adverse reaction/event (SAR/SAE) with previous Tetanus and Diphtheria immunizations.
•10.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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