Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-01-22 @ 9:12 AM
Study NCT ID:
NCT01870206
Status:
UNKNOWN
Last Update Posted:
2013-09-30
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
Sponsor:
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Organization:
Study Overview
Official Title:
Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: