Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (336 subjects), and neonates (1155 subjects).

Inclusion Criteria for all participants:Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigatorParent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedureResides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator)Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted scheduleInclusion Criteria for Cohort 1 (young children) participants only:Male or female child from 1 to less than 5 years of age at the time of initial study vaccinationBased on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing OPV (may have also received IPV), with last dose received more than 3 months prior to initial study vaccinationInclusion Criteria for Cohort 2 (infants) participants only:Male or female infant expected to be 6 weeks of age (43rd to 49th day of life [with day of birth being the first day of life], inclusive+ 6-day window), at the time of initial study vaccinationPrior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation.Inclusion Criteria for Cohort 3 (neonates) participants only:Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccinationPrior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based on no evidence of such vaccination per available documentation.Exclusion Criteria for all participants:For all participants, the 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 at the time of study vaccine administration. For household members younger than 10 years of age, "age appropriate" vaccination is complete series of trivalent Oral Poliovirus Vaccine (tOPV) or at least three doses of bivalent (types 1 and 3) Oral Poliovirus Vaccine (bOPV) plus a booster fractional dose of IPV (fractional dose Inactivated Polio Vaccine; fIPV).For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration.Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 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)Evidence of a clinically significant congenital or genetic defect as judged by the investigatorHistory of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (> 0.5mg/kg/day of prednisolone (or equivalent)). Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the infant/young child)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)Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household memberAny known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection