Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

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

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.

Study Overview

• Status: Unknown
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: Trivalent OPV Birmex; Biological: Trivalent OPV Sanofi Pasteur

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 Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Estado de México
    • Valle de Chalco, Estado de México, Mexico, 56613
      • Recruiting
      • Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
      • Principal Investigator: Monserrat Ávila-Flores, Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: tOPV

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Poliovirus Excretion	Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans

Collaborators and Investigators

• Sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
• Investigators: Principal Investigator: Mauricio Rodríguez Álvarez, PhD, Laboratorios de Biológicos y Reactivos de México S.A de C.V

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): September 30, 2013
• Last Update Submitted That Met QC Criteria: September 27, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Immunogenicity; Newborn; Poliomyelitis
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: Birmex-ECA-01-2013