A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose i… (NCT07010822) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Bangladesh740 participantsStarted 2025-12-08
Plain-language summary
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).
Who can participate
Age range1 Day – 7 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
✕. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
✕. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
✕. Acute severe febrile illness (≥37.5 °C) on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).