Status:
COMPLETED
Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV Vaccine
Lead Sponsor:
Fidec Corporation
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
Conditions:
Poliomyelitis
Eligibility:
All Genders
5+ years
Phase:
PHASE4
Brief Summary
This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously va...
Detailed Description
The world polio eradication effort is near its goal of reducing the number of new cases of polio to zero. However, final and definitive eradication of the disease will require stopping the use of oral...
Eligibility Criteria
Inclusion
- Age: 6 weeks (-7 to +14 days).
- Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parents or legal guardian as per country regulations
Exclusion
- Previous vaccination against poliovirus.
- Low birth weight (BW \<2,500 gm).
- Multiple pregnancy (twins, triplets, etc.),
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination.
- Member of the subject's household (living in the same house or apartment unit) who has received OPV vaccine in the last 3 months.
- Subject who, in the opinion of the Investigator or sub-Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
1420 Patients enrolled
Trial Details
Trial ID
NCT01831050
Start Date
May 1 2013
End Date
December 1 2014
Last Update
August 6 2015
Active Locations (4)
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1
Centro de Estudios en Infectologia Pediatrica - CEIP
Cali, Cali, Colombia
2
Hospital Maternidad Nuestra Señora de la Altagracia
Santo Domingo, Dominican Republic
3
Clinica Niño Sano Hospital Roosevelt
Guatemala City, Departamento de Guatemala, Guatemala, 01011
4
Hospital del Niño de Panama
Panama City, Provincia de Panamá, Panama