The study will compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).
Newborn infants of maximum 1 week of age with birth weight > 2,500 g.
Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by medical history and physical examination.
Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
Resides in the area and parents willing to adhere to all study procedures.
Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the participant's household.
Household member who has receive any novel OPV 1 month before birth of this study's participant up through 1 month post-last-dose.
Family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
Fidec Corporation
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator