Trial record 9 of 18 for:    Open Studies | "Poliomyelitis"

Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Sponsor:
Information provided by (Responsible Party):
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01870206
First received: May 15, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Poliomyelitis
Biological: Trivalent OPV Birmex
Biological: Trivalent OPV Sanofi Pasteur
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans

Resource links provided by NLM:


Further study details as provided by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.:

Primary Outcome Measures:
  • Change seroconversion after one dose of trivalent vaccine OPV [ Time Frame: after the first dose is taken blood samples (baseline, 30 and 60 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the adverse events in newborns babies [ Time Frame: inmediately after treatment and during 60 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Poliovirus Excretion [ Time Frame: Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: June 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: tOPV

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

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870206

Contacts
Contact: Alvaro García-Pérez, MD 5554222840 ext 139 agarciap@birmex.gob.mx

Locations
Mexico
Hospital General de Chalco Dr. Fernando Quiroz Gutierrez Recruiting
Valle de Chalco, Estado de México, Mexico, 56613
Principal Investigator: Monserrat Ávila-Flores, Pediatrics         
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01870206     History of Changes
Other Study ID Numbers: Birmex-ECA-01-2013
Study First Received: May 15, 2013
Last Updated: September 27, 2013
Health Authority: México: Comisión Federal para la Protección contra Riesgos Sanitarios

Keywords provided by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.:
Immunogenicity
Safety
Efficacy
Poliomyelitis
Newborn

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 16, 2014