Immunogenicity and safety of intradermal injection of reduced dose Inactivated Poliovirus vaccine (IPV) with a jet injector in healthy adults - Intradermal injection of reduced dose IPV with a jet injector in adults

ederlands Vaccin Instituut0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Subjects have to fulfill all of the following criteria:
•Age >= 18 years
•Good health according to the investigator
•Must have received in total 6 combined DTP-IPV vaccinations according to the National Immunization Programme as a child (before 11 years of age) and must not have received any polio vaccination since then.
•Willingness and ability to adhere to the study regimen
•Having a signed informed consent form

•Any of the following criteria will exclude a volunteer from participation, at start of this study:
•IPV booster dose after 10 years of age
•Known or suspected allergy against any of the vaccine components
•History of unusual or severe reactions to any previous vaccination
•Known or suspected disease or use of medication that may influence the immune system
•Administration of plasma or blood products three months prior to the study
•Any vaccination within one month prior to the study
•History of any neurological disorder including epilepsy or febrile seizures
•Evidence of excessive alcohol use or drug use
•Females not willing to use contraceptives during the first 28 days following vaccination, or if breastfeeding
•Bleeding disorders or the usage of anticoagulants
•Delay criteria
•If body temperature >= 38.0°C this will lead to postponement of participation. Screening may continue when the temperature has normalized.

发起方

ederlands Vaccin Instituut