Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama (NCT05654467) | Clinical Trial Compass
UnknownPhase 2
Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
Panama1,532 participantsStarted 2023-12-05
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 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).
Who can participate
Age range1 Day 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(s) or guardian(s) 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(s) or guardian(s) agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol adjusted schedule.
ā. Male or female child from ā„1 to \<5 years-of-age at the time of initial study vaccination.
ā. Based on available documentation or parental/guardian(s) report, previously completed the primary poliomyelitis immunization series for the jurisdiction, with last dose received more than 28 days 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 parental/guardian(s) report or 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 appropriate vaccination is complete series of the primary poliomyelitis immunization series for the jurisdiction.
What they're measuring
1
Frequency of serious adverse events (SAEs)
Timeframe: Up to last visit for last subject, around 18 months
2
Frequency of solicited adverse events (AEs) for 7 days (day of vaccination and 6 following days) after each vaccination
Timeframe: 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 3 anti-polio serum neutralizing antibody (NAb) in infants.
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 three 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 (see Appendix II: Severity Grading Tables). 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. 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. 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).
ā. Receipt of any systemic immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member.