Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01870206
• Other study ID #: Birmex-ECA-01-2013
• Status: Recruiting
• Phase: Phase 3
• First received: May 15, 2013
• Last updated: September 27, 2013
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2013
• Source: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
• Contact: Alvaro García-Pérez, MD
• Phone: 5554222840
• Email: agarciap[@]birmex.gob.mx
• Is FDA regulated: No
• Health authority: México: Comisión Federal para la Protección contra Riesgos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Hospital General de Chalco Dr. Fernando Quiroz Gutierrez	Valle de Chalco	Estado de México

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Poliovirus Excretion		Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans	No
Primary	Change seroconversion after one dose of trivalent vaccine OPV		after the first dose is taken blood samples (baseline, 30 and 60 days)	Yes
Secondary	Evaluate the adverse events in newborns babies		inmediately after treatment and during 60 days	Yes

External Links

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