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

Summary

This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and safety.

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).

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Fidec Corporation

  lead OTHER

Principal Investigators

• Edwin J Asturias, MD · University of Colorado, Denver

• Ricardo Ruttimann, MD · Fidec Corporation

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

5 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-04-30

Completion

2014-12-31

Countries

• Colombia
• Dominican Republic
• Guatemala
• Panama

Study Locations