Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
NCT ID: NCT01870206
Last Updated: 2013-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
320 participants
INTERVENTIONAL
2013-06-30
2014-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight ≥ 2.5 kg
* Have not received any doses of Polio Vaccine
* Whose parents or guardians reside in the work area
* Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).
Exclusion Criteria
* Weight ≤ 2.5 kg
* Presence of fever, diarrhea, known immunosuppression, respiratory infections.
* Treatment with immunosuppressants.
* Having neurological diseases.
* Require or received surgery in oropharynx.
1 Day
2 Weeks
ALL
No
Sponsors
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Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
OTHER
Responsible Party
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Principal Investigators
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Mauricio Rodríguez Álvarez, PhD
Role: PRINCIPAL_INVESTIGATOR
Laboratorios de Biológicos y Reactivos de México S.A de C.V
Locations
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Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
Valle de Chalco, State of Mexico, Mexico
Countries
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Central Contacts
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Related Links
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Laboratorios de Biológicos y Reactivos de México S.A de C.V
Other Identifiers
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Birmex-ECA-01-2013
Identifier Type: -
Identifier Source: org_study_id