Safety and Immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy adults

World Health Organization0 个研究点目标入组 30 人开始时间: 2012年4月27日最近更新: 2020年1月13日

试验速览

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•Subjects must fulfill all of the following criteria:
•- University student attending the Faculty of Chemistry and Pharmacology, Camaguey University, Camaguey
•- Age 18 to 24, inclusive at the time of enrollment
•- In good health as determined by the outcome of medical history, physical examination screening/baseline labs, and clinical judgment of the investigator
•- Must have received polio vaccinations with OPV according to the Cuban National Immunization Program as a child
•- Preferred: number (and date) of polio vaccinations known
•- Willingness and ability to adhere to the study regimen
•- Having a signed informed consent form

•Temporary exclusion criteria for vaccination:
•- If body temperature >=38C this will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
•The exclusion criteria for vaccination are:
•- IPV or OPV booster dose after the age of 12 years
•- 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
•- Known or suspected immune deficiency
•- Systemic treatment with corticosteroids within one month before screening
•- Administration of plasma (including immunoglobulins) or blood products three months prior to the study
•- Blood donation within one month before screening
•- Any vaccination within three months before screening and during the study until the last visit
•- History of any neurological disorder including epilepsy or febrile seizures
•- Evidence of excessive alcohol use or drug use
•- Any infectious disease
•- Participation in another clinical trial within three months before screening
•- Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
•The exclusion criteria for blood collections are:
•- Bleeding disorders or the usage of anticoagulants

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