A non-randomised cohort study to evaluate immunogenicity and reactogenicity of adult formulation diphtheria-tetanus-pertussis vaccine in healthy adult healthcare workers and researchers working with children: a comparison of those who have previously received a booster and those who are previously unvaccinated

Telethon Kids Institute0 个研究点目标入组 150 人开始时间: 2015年11月19日最近更新: 2020年1月13日

适应症

试验速览

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•1.Healthy adults 23 - 64 years of age employed in the Child and Adolescent Health
•Service, North and South Metro Health Service, University of WA School of Paediatrics
•and Child Health and/or Telethon Kids Institute, in general good health, available for
•the duration of the study.
•2.Participants will have either received a dTPa vaccine 7-10 years previously or have not
•received a pertussis containing vaccine since childhood (<15 years of age).

•1.History of pertussis, tetanus or diphtheria vaccination or confirmed pertussis in the
•previous 5 years;
•2.Immunosuppressive therapy or known immunodeficiency;
•3.Immunoglobulins and blood products within 3 months prior to or during the trial;
•4.Acute febrile illness at the time of enrolment; or previous record, following of serious
•adverse reaction to diphtheria-tetanus-pertussis vaccination or component antigens.
•5.Females will be excluded if they are pregnant/ or nursing.
•6.Contraindications to vaccination as listed in the current NHMRC Australian
•Immunisation Handbook 10th Edition or as listed in the Boostrix 'Trademark' Product
•Information. dTpa vaccine will not be administered to individuals known to be
•hypersensitive to any component of the vaccine or residues carried over from
•manufacture (such as formaldehyde and glutaraldehyde).
•7.History of serious chronic illness or condition which in the judgement of the clinical
•investigator would preclude study participation.
•8.History of neurologic disease or seizure (excluding simple febrile seizure).

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