Status:
UNKNOWN
Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
Lead Sponsor:
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Conditions:
Poliomyelitis
Eligibility:
All Genders
1-2 years
Phase:
PHASE3
Brief 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...
Detailed 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 OP...
Eligibility Criteria
Inclusion
- Newborns babies
- 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
- Born of a high-risk pregnancy.
- Weight ≤ 2.5 kg
- Presence of fever, diarrhea, known immunosuppression, respiratory infections.
- Treatment with immunosuppressants.
- Having neurological diseases.
- Require or received surgery in oropharynx.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01870206
Start Date
June 1 2013
End Date
January 1 2014
Last Update
September 30 2013
Active Locations (1)
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1
Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
Valle de Chalco, State of Mexico, Mexico, 56613