A Phase 3 interventional study of Trivalent OPV Birmex and Trivalent OPV Sanofi Pasteur in Poliomyelitis, sponsored by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.. Status unknown at 1 site in Mexico. Open to participants aged 1 Day to 2 Weeks. Per ClinicalTrials.gov, last updated 2013-09-30.
Sponsored by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. · Phase 3 and Interventional
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.
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
222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.
This study's planned enrollment of 320 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Newborns receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine. A second dose four weeks after the first application.
Biological: Trivalent OPV Birmex
Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine. A second dose four weeks after the first application.
Biological: Trivalent OPV Sanofi Pasteur
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.
Also known as: tOPV
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.
Also known as: tOPV
Change seroconversion after one dose of trivalent vaccine OPV
Time frame: after the first dose is taken blood samples (baseline, 30 and 60 days)
Evaluate the adverse events in newborns babies
Time frame: inmediately after treatment and during 60 days
Poliovirus Excretion
Time frame: Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans
This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.