Status:
UNKNOWN
Immunogenicity of 1 or 2 Doses of bOPV in Chilean Infants Primed With IPV Vaccine
Lead Sponsor:
University of Chile
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Polio
Eligibility:
All Genders
7-9 years
Phase:
PHASE4
Brief Summary
The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide evidence for be...
Detailed Description
3.0 STUDY DESIGN This is a multicenter, randomized, unblinded study. Healthy infants attending the well-child care at outpatient clinics and due for their first dose of polio vaccines will be eligible...
Eligibility Criteria
Inclusion
- Age: 8 weeks (-7 to +7 days).
- Healthy infants of all ethnicities and both genders 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 parent or legal guardian who, in the opinion of the investigator, is capable of understanding and complying with the protocol requirements.
Exclusion
- Previous vaccination against poliovirus.
- Low birth weight (BW \<2,500 grams).
- Twins or multiple pregnancy infants.
- Another family or household member who has received OPV within the past 6 months or is going to receive OPV within the following 6 months.
- Any confirmed or suspected immunosuppressive or immunedeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious 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.
- Subject who, in the opinion of the 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 :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT01841671
Start Date
April 1 2013
End Date
June 1 2014
Last Update
May 20 2014
Active Locations (1)
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1
Facultad de Medicina de la Universidad de Chile
Santiago, Santiago Metropolitan, Chile, 8380453