NCT01870206

Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. · Academic / Other
• Sex: All
• Age: 1 Day – 2 Weeks
• Healthy volunteers: Not accepted

Summary

Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life. Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.

Detailed description

This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent OPV Birmex	Newborns who receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
BIOLOGICAL	Trivalent OPV Sanofi Pasteur	Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-06-05
• Last updated: 2013-09-30

Locations

1 site across 1 country: Mexico