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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

2,400

Participants

Timeline

Start Date

November 20, 2024

Primary Completion Date

December 15, 2027

Study Completion Date

December 15, 2027

Conditions
Poliomyelitis
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.

Trial Locations (2)

1212

NOT_YET_RECRUITING

International Centre for Diarrhoeal Disease Research, Dhaka

Unknown

RECRUITING

International Centre for Diarrhoeal Disease Research, Dhaka

All Listed Sponsors
collaborator

Bio Farma, Indonesia

UNKNOWN

lead

PATH

OTHER