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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01870206

Enrollment

320

Registered

2013-06-05

Start date

2013-06-30

Completion date

2014-01-31

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poliomyelitis

Keywords

Immunogenicity, Safety, Efficacy, Poliomyelitis, Newborn

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.

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

Interventions

BIOLOGICALTrivalent 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.

BIOLOGICALTrivalent 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 2 Weeks

Healthy volunteers

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.

Design outcomes

Primary

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

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

Other

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

Countries

Mexico

Contacts

Primary ContactAlvaro García-Pérez, MD

agarciap@birmex.gob.mx5554222840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026