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

World Health Organization0 sites30 target enrollmentApril 27, 2012

Overview

No summary available.

Registry

who.int

Start Date

April 27, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Sponsor

•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