Status:
COMPLETED
Comparison of Immune Response Using 2 Vaccination Schedules Using Inactivated Polio Vaccine
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
San Lucas Hospital, Ponce, Puerto Rico
Conditions:
Poliomyelitis
Eligibility:
All Genders
1-48 years
Phase:
NA
Brief Summary
As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus vaccination need to be established. One strategy would be to use inactivated poliovirus vaccine (IPV) transition...
Detailed Description
The proposed study will be a prospective, randomized clinical trial of the immunogenicity of IPV among two groups of infants using different immunization schedules (WHO/EPI and US). Study will begin ...
Eligibility Criteria
Inclusion
- Infants under 48 hours of age born at San Lucas Hospital during study enrollment period
- Infants with gestational age of \> 37 weeks as assessed by neonatologist
- Mother/guardian gives informed consent
- Infant is expected to reside in Puerto Rico for the following 8 months
Exclusion
- Mother/guardian does not speak English or Spanish
- Mother/guardian has religious/philosophical objection to immunizations
- Infant has serious chronic or acute health problems that require hospitalization immediately (within 1 day) after birth (assessed by infant not being placed in San Lucas Hospital well-baby clinic)
- Mother expects to travel with infant during study period to a country known to have circulating poliovirus or that uses oral poliovirus vaccine (OPV)
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00137696
Start Date
July 1 2003
End Date
July 1 2004
Last Update
May 31 2024
Active Locations (1)
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1
Ponce School of Medicine
Ponce, Puerto Rico