Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-4
SponsorPATH
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 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).
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(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).
Parent(s) or guardian(s) 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 appropriate vaccination is complete series of the primary poliomyelitis immunization series for the jurisdiction.
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.
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 (see Appendix II: Severity Grading Tables). 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 3 Oral Poliomyelitis Vaccine (nOPV3)
- Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)
Treatment groups
1,532 Participants
are divided into 12 treatment groups12
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
Technical Resources International, Inc.
Collaborator
Source ClinicalTrials.gov