About this trial
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 (720 subjects), and neonates (1320 subjects).
Eligibility criteria
Qualifiers
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 investigator
Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure
Resides 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 schedule
Disqualifiers
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). Note: A vaccination series of tOPV or at least three doses of bOPV with our without a booster fractional dose of IPV will be considered sufficient.
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.
Trial design
Treatments tested in this trial
- Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
- Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Treatment groups
15
Treatment groupsSee each treatment group below.
Sponsors and collaborators
PATH
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
PT Bio Farma
Collaborator
Centers for Disease Control and Prevention
Collaborator
DiagnoSearch Life Sciences Pvt. Ltd.
Collaborator