Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh (NCT05644184) | Clinical Trial Compass
RecruitingPhase 2
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Bangladesh2,232 participantsStarted 2023-03-27
Plain-language summary
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).
Who can participate
Age range0 Days ā 4 Years
SexALL
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Inclusion criteria
ā. 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
ā. Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure
ā. 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)
ā. Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule
ā. Male or female child from 1 to less than 5 years of age at the time of initial study vaccination
ā. Based 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 vaccination
ā. 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 vaccination
ā. Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation.
Exclusion criteria
ā. 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.
What they're measuring
1
Frequency of serious adverse events (SAEs) from the time of first study vaccination through the end of the study
Timeframe: From Day 1 to end of study, up to Day 197 (young children and neonates) or Day 225 (infants)
2
Frequency of solicited adverse events (AEs) for 7 days (day of vaccination and 6 following days) after each vaccination
Timeframe: From vaccination to 7 days post vaccination
3
Frequency of unsolicited AEs for 28 days (day of vaccination and 27 following days) after each vaccination
Timeframe: From vaccination to 28 days post vaccination
4
Post-vaccination frequency of seroconversion of type 1 anti-polio serum neutralizing antibody (NAb).
ā. 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.
ā. Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
ā. Moderate or severe (grade ā„ 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.
ā. Presence of fever on the day of enrollment/first study vaccination (axillary temperature ā„37.5ĖC) - (Temporary exclusion for Cohorts 1 and 2)
ā. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
ā. Evidence of a clinically significant congenital or genetic defect as judged by the investigator
ā. History 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)