Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Exclusion Criteria

• •1. Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.
• •2. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
• •3. Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound).
• •4. Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.
• •5. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
• •6. Moderate or severe (grade ≥ 2) acute illness including vomiting, diarrhea at the time of enrollment/first study vaccination - temporary exclusion.
• •7. Presence of fever within the 72 hours of the day of enrollment/first study vaccination (oral temperature ≥38.0˚C for Cohort 1; axillary temperature ≥37.5˚C for Cohorts 2 and 3) or any antipyretic use within past 24 hours - temporary exclusion for Cohorts 1 and 2.
• •8. Evidence of a clinically significant major congenital or genetic defect as judged by the investigator.
• •9. History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (\> 0.5mg/kg/day or 20 mg/day of prednisolone (or equivalent) within 6 months prior to first study vaccine dose. Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the young child).
• •10. Participation in another investigational product (drug or vaccine, including prior polio vaccine trials) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned participation in another investigational product clinical trial during the study period.
• •11. Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned during the study period.
• •12. Participant or parent, when applicable, has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).
• •13. Receipt of polio vaccine within 12 months before the start of the study.
• •14. Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel.
• •15. Will have household direct or close professional contact during the study with pregnant women.
• •16. Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., soiling of underwear with stool by children who are past the age of toilet training or other individuals, including adults, with fecal incontinence).
• •17. Will have professional handling of food, catering, or food production activities during the study.
• •18. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
• •19. Presence of severe malnutrition \[weight-for-length/height z-score \<-3SD median (per WHO published child growth standards)\]-temporary exclusion if marginal and subsequently gains weight.
• •20. Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth or by the time of enrollment
• •21. Premature birth (less than 37 weeks gestation).
• •22. From multiple birth (due to increased risk of OPV transmissions between siblings).