Status:
COMPLETED
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Lead Sponsor:
Fidec Corporation
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Poliomyelitis
Eligibility:
All Genders
5-7 years
Phase:
PHASE3
Brief Summary
The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (...
Detailed Description
This study prioritizes comparisons involving two-dose regimens recently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE) and Pan American H...
Eligibility Criteria
Inclusion
- Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.
- Healthy, as assessed from medical history and physical examination by a study physician,
- Written informed consent obtained from parents or legal representatives who have been properly informed about the study and are able to comply with planned study procedures.
Exclusion
- Vaccinated with any poliovirus vaccine prior to inclusion,
- A household contact with OPV vaccination history in the past 4 weeks,
- HIV infection or pharmacologic immunosuppression,
- Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections,
- Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be a contraindication for vaccination,
- Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2018
Estimated Enrollment :
773 Patients enrolled
Trial Details
Trial ID
NCT03239496
Start Date
October 23 2017
End Date
November 13 2018
Last Update
July 21 2023
Active Locations (4)
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1
Hospital Universitario Nuestra Señora de la Alta Gracia
Santo Domingo, Dominican Republic
2
Cevaxin Vaccination Center
David, Panama
3
Cevaxin Vaccination Center
La Chorrera, Panama
4
Cevaxin Vaccination Center
Panama City, Panama