Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

Poliomyelitis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Poliomyelitis

• NCT number: NCT01870206
• Study type: Interventional
• Source: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
• Contact: Alvaro García-Pérez, MD
• Phone: 5554222840
• Email: agarciap@birmex.gob.mx
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2013
• Completion date: January 2014