CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 1,532 target
Drug / intervention
Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3) +1 morebiological
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Healthy, without clinically significant medical condition or congenital anomaly
  • ✓Parent(s) or guardian(s) willing and able to provide written informed consent
  • ✓Resides in study area and able to adhere to all study visits and procedures
  • ✓Parent(s) or guardian(s) agrees for participant to receive all routine infant and childhood immunizations per approved protocol
Key exclusion· 15
  • ✕Household member <10 years without complete age-appropriate poliovirus vaccination
  • ✕Household member received OPV in previous 3 months before study vaccine administration
  • ✕Attending day care or pre-school during participation until one month after last study vaccine
  • ✕Moderate or severe acute illness (grade ≥2) at enrollment/first vaccination

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05654467
NCT05654467Phase 2RecruitingOn Track
CompareCT.gov

A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama

PATH·interventional·Posted Dec 16, 2022·Updated May 11, 2026

In Brief

A Phase 2 clinical trial evaluating Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3) and Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3) for Poliomyelitis. Currently recruiting, targeting 1,532 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesPanama
CollaboratorsBill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, Technical Resources International, Inc.

Timeline

Phase 2Recruiting
20232024202520262027
First PostedDec 16, 2022
Enrollment StartDec 5, 2023
Primary CompletionMar 20, 2027
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 3.5 years agoPrimary completion in 9 months

Interventions

Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3)biological

The nOPV3 vaccine containing approximately 10\^5.5, 10\^6.0, or 10\^6.5 CCID50 per dose.

Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)biological

The Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 control and challenge vaccine (mOPV3) containing ≥ 10\^5.8 CCID50 per dose.