Comparison of immune response of fractional doses, administered intradermally vs. full doses administered intramuscularly of inactivated poliovirus vaccine (IPV) in male adults in Camaguey, Cuba.

World Health Organization0 个研究点目标入组 600 人开始时间: 2015年4月1日最近更新: 2020年1月13日

适应症

试验速览

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•Subjects have to fulfill all of the following criteria:
•*Males age 18 to 30, inclusive at the time of enrollment; and
•*in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; and
•*must have received polio vaccinations with at least one dose of OPV according to the Cuban National Immunization Program as a child; and
•*willing to sign an informed consent form.

•The exclusion criteria for vaccination are
•* IPV or OPV booster dose after the age of 12 years; or
•* Known or suspected exposure to wild poliovirus
•* known or suspected allergy against any of the vaccine components; or
•* history of unusual or severe reactions to any previous vaccination; or
•* known or suspected disease or use of medication that may influence the immune system; or
•* known or suspected immune deficiency, and/or known HIV infection; or
•* systemic treatment with corticosteroids or immunosuppressant within one month before screening or during the study; or
•* administration of plasma (including immunoglobulins) or blood products three months prior to the study during the study; or
•* blood donation within one month before screening; or
•* any vaccination within three months before screening and during the study until the last visit; or
•* history of any neurological disorder including epilepsy or febrile seizures; or
•*evidence of excessive alcohol use or drug use; or
•*any infectious disease; or
•*participation in another clinical trial within three months before enrollment.
•*Bleeding disorders or the usage of anticoagulants.

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