At a glance
ClinicalIndex Comparison Record- ✓Healthy with no clinically significant medical condition or congenital anomaly
- ✓Parent/guardian willing to provide written informed consent
- ✓Resides in study area and parent able to adhere to all study visits and procedures
- ✓Parent agrees participant receives all routine infant and childhood immunizations per protocol-adjusted schedule
- ✕Household member under 10 years without age-appropriate poliovirus vaccination (complete tOPV or ≥3 bOPV doses plus booster fIPV)
- ✕Household member received OPV in previous 3 months before study vaccine administration
- ✕Children 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 (temporary exclusion)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05644184Phase 2RecruitingMonitorUpdated 5mo ago · Completion was 1mo agoA Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Bangladesh
In Brief
A Phase 2 clinical trial evaluating Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) and Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1) for Poliomyelitis. Currently recruiting, targeting 2,232 participants across 1 site.
Signals
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 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).
Study Details
Timeline
Interventions
Drop counts of nOPV vaccine will be varied to achieve approximately 10\^5.5, 10\^6.0, 10\^6.5 CCID50 or 10\^7.0, 10\^7.5 dose levels.
The Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 control and challenge vaccine (mOPV1) contains ≥ 10\^6.0 CCID50 per 0.1 mL (2 drops) dose.