At a glance
ClinicalIndex Comparison Record- ✓Healthy with no clinically significant medical condition or congenital anomaly
- ✓Willing and able to provide written informed consent
- ✓Resides in study area and able to adhere to all study visits and procedures
- ✓Cohort 1: Ages 18-45 years at enrollment
- ✕Household member under 10 years without complete age-appropriate poliovirus vaccination (at least 3 doses OPV)
- ✕Known allergy or hypersensitivity to vaccine components, macrolides, or aminoglycosides
- ✕Known or suspected immunosuppressive or immunodeficiency condition including HIV in participant or household member
- ✕Receipt of immune-modifying or immunosuppressant drugs within 6 months prior to first vaccine dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh
In Brief
A Phase 2 clinical trial evaluating Novel oral poliomyelitis vaccine type 1 (nOPV1), Novel oral poliomyelitis vaccine type 2 (nOPV2), and 2 other interventions for Poliomyelitis. Currently recruiting, targeting 2,400 participants across 2 sites.
Detailed Summary
The main objectives of this study are to : * evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; * evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. * compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; * evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Study Details
Timeline
Interventions
Live attenuated novel poliomyelitis virus type 1 at two different dosages, containing middle-dose (MD) 10\^6.0, or high-dose (HD) 10\^6.5 CCID₅₀/dose
Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10\^5.3 and HD 10\^5.6 CCID₅₀/dose.
Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10\^6.0, or HD 10\^6.5 CCID₅₀/dose.
Live attenuated poliomyelitis viruses types 1 and 3 (Sabin strains). Each dose (2 drops = 0.1 mL) contains not less than 10\^6.0 infective units of type 1 and 10\^5.8 of type 3.