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RECRUITING
NCT06137664
PHASE1/PHASE2

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Sponsor: PATH

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

0 Days - 45 Years

Study Type

INTERVENTIONAL

Enrollment

2400

Start Date

2024-11-20

Completion Date

2027-12-15

Last Updated

2025-06-03

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Novel oral poliomyelitis vaccine type 1 (nOPV1)

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

BIOLOGICAL

Novel oral poliomyelitis vaccine type 2 (nOPV2)

Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10\^5.3 and HD 10\^5.6 CCID₅₀/dose.

BIOLOGICAL

Novel oral poliomyelitis vaccine type 3 (nOPV3)

Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10\^6.0, or HD 10\^6.5 CCID₅₀/dose.

BIOLOGICAL

Bivalent Oral Poliomyelitis Vaccine (bOPV)

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.

Locations (2)

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh