Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
Recruitment status was: Recruiting
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.
|Poliomyelitis||Biological: Trivalent OPV Birmex Biological: Trivalent OPV Sanofi Pasteur||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
|Official Title:||Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans|
- 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 ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Trivalent OPV Birmex
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 Birmex one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
Other Name: tOPV
Active Comparator: Trivalent OPV Sanofi Pasteur
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 Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
Other Name: tOPV
Please refer to this study by its ClinicalTrials.gov identifier: NCT01870206
|Contact: Alvaro García-Pérez, MD||5554222840 ext firstname.lastname@example.org|
|Hospital General de Chalco Dr. Fernando Quiroz Gutierrez||Recruiting|
|Valle de Chalco, Estado de México, Mexico, 56613|
|Principal Investigator: Monserrat Ávila-Flores, Pediatrics|
|Principal Investigator:||Mauricio Rodríguez Álvarez, PhD||Laboratorios de Biológicos y Reactivos de México S.A de C.V|