Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV Vaccine

PHASE4CompletedINTERVENTIONAL
Enrollment

1,420

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

December 31, 2014

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

Bivalent Oral Polio Vaccine (bOPV)

Produced by Sanofi Pasteur, Lyon, France, bivalent OPV vaccine contains types 1 and 3 polioviruses and it is indicated for supplementary immunization activities in children from 0 to 5 years of age to prevent or contain outbreaks caused by these 2 serotypes.

BIOLOGICAL

Trivalent Oral Polio Vaccine (tOPV)

Produced by Sanofi Pasteur, Lyon, France, trivalent OPV vaccine contains types 1, 2, and 3 polioviruses and it is indicated for routine and supplementary prevention of poliomyelitis in children from 0 to 5 years of age.

BIOLOGICAL

Monovalent Oral Polio Vaccine Type 2 (mOPV2)

Licensed monovalent OPV type 2 vaccine (mOPV2) by Glaxo SmithKline, Rixensart, Belgium. Polio Sabin Mono Two (oral) is a monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells.

BIOLOGICAL

Sanofi-Pasteur IPV (Sanofi IPV)

Inactivated poliovirus vaccine is produced by Sanofi-Pasteur as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).

BIOLOGICAL

Glaxo SmithKline IPV (GSK IPV)

Inactivated poliovirus vaccine is produced by Glaxo SmithKline, Rixensart, Belgium, as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).

BIOLOGICAL

Serum Institute of India IPV (SII IPV)

Inactivated poliovirus vaccine produced by Nederland's Vaccin Instituut in Bilthoven, The Netherlands (acquired recently by Serum Institute of India \[SII\]) is licensed in the producing country and prequalified by the WHO. It consists of a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).

Trial Locations (4)

Unknown

Centro de Estudios en Infectologia Pediatrica - CEIP, Santiago de Cali

Hospital Maternidad Nuestra Señora de la Altagracia, Santo Domingo

Hospital del Niño de Panama, Panama City

01011

Clinica Niño Sano Hospital Roosevelt, Guatemala City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Centers for Disease Control and Prevention

FED

lead

Fidec Corporation

OTHER

NCT01831050 - Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV Vaccine | Biotech Hunter | Biotech Hunter