Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

Phase 3

• Conditions: Poliomyelitis
• Interventions: Biological: Trivalent OPV Birmex; Biological: Trivalent OPV Sanofi Pasteur

• Registration Number: NCT01870206
• Lead Sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

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 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

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

Study Timeline

• Study First Submitted: 2013-05-15
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trivalent OPV Birmex	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 Sanofi Pasteur	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluate the adverse events in newborns babies	inmediately after treatment and during 60 days

Trial Locations

Locations (1)

Hospital General de Chalco Dr. Fernando Quiroz Gutierrez; 🇲🇽 Valle de Chalco, Estado de México, Mexico