Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

NCT01870206 | Unknown Phase 3 DMC

• 1 other identifier: Birmex-ECA-01-2013
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis

Keywords

Immunogenicity; Safety; Efficacy; Poliomyelitis; Newborn

Outcome Measures

Primary Outcomes (1)

• Change seroconversion after one dose of trivalent vaccine OPV

  after the first dose is taken blood samples (baseline, 30 and 60 days)

Secondary Outcomes (1)

• Evaluate the adverse events in newborns babies

  inmediately after treatment and during 60 days

Other Outcomes (1)

• Poliovirus Excretion

  Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans

Study Arms (2)

Trivalent OPV Birmex

EXPERIMENTAL

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

Trivalent OPV Sanofi Pasteur

ACTIVE COMPARATOR

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

Interventions

Trivalent OPV Birmex BIOLOGICAL

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.

Also known as: tOPV

Trivalent OPV Birmex

Trivalent OPV Sanofi Pasteur BIOLOGICAL

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.

Also known as: tOPV

Trivalent OPV Sanofi Pasteur

Eligibility Criteria

• Age: 1 Day - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.: lead

Study Sites (1)

Hospital General de Chalco Dr. Fernando Quiroz Gutierrez

Valle de Chalco, State of Mexico, 56613, Mexico

RECRUITING

Related Links

• Laboratorios de Biológicos y Reactivos de México S.A de C.V

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Mauricio Rodríguez Álvarez, PhD

  Laboratorios de Biológicos y Reactivos de México S.A de C.V

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro García-Pérez, MD

CONTACT

5554222840; agarciap@birmex.gob.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

ME (1)