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Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

NCT01870206 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2013-09-30

No results posted yet for this study

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.

Conditions

  • Poliomyelitis

Interventions

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.

Sponsors & Collaborators

  • Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

    lead OTHER

Principal Investigators

  • Mauricio Rodríguez Álvarez, PhD · Laboratorios de Biológicos y Reactivos de México S.A de C.V

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870206 on ClinicalTrials.gov