Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

June 17, 2016

Study Completion Date

June 17, 2016

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1

Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 cell culture infectious dose 50% (CCID50)/dose and 10\^5.8 CCID50/dose, respectively.

BIOLOGICAL

BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2

Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10\^6 CCID50/dose and 10\^5.8 CCID50/dose, respectively.

BIOLOGICAL

BioFarma Bivalent Oral Poliomyelitis Vaccine

Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 and 10\^5.8 infective units per dose, respectively.

Trial Locations (2)

PO Box 54-40100

Kenya Medical Research Institute/Walter Reed Project, Kisumu

Unknown

Kenya Medical Research Institute (KEMRI)/Walter Reed Project, Kericho

All Listed Sponsors
collaborator

Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio

UNKNOWN

lead

PATH

OTHER

NCT02434770 - Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine | Biotech Hunter | Biotech Hunter