Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Trivalent OPV Birmex
* Biological: Trivalent OPV Sanofi Pasteur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trivalent OPV Birmex<br>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<br>* 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.<br>* Other names: tOPV;|
| Active Comparator: Trivalent OPV Sanofi Pasteur<br>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<br>* 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.<br>* Other names: tOPV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change seroconversion after one dose of trivalent vaccine OPV |  | after the first dose is taken blood samples (baseline, 30 and 60 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the adverse events in newborns babies |  | inmediately after treatment and during 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Safety, Efficacy, Poliomyelitis, Newborn