Status:
TERMINATED
Immunogenicity of Intramuscular and Intradermal IPV
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Poliomyelitis
Eligibility:
All Genders
42-48 years
Phase:
PHASE4
Brief Summary
This is an open-label phase IV randomized clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliov...
Detailed Description
Oral poliovirus vaccine (OPV) cessation is essential to achieve eradication of polio as OPV contains live poliovirus, which can mutate and become neurovirulent. After OPV cessation, inactivated poliov...
Eligibility Criteria
Inclusion
- Healthy infants 6 weeks of age
- Parents that consent for participation in the full length of the study.
- Parents that are able to understand and comply with planned study procedures.
Exclusion
- Parents and infants who are unable to participate in the full length of the study.
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
- Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
- Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
- Infants from premature births (\<37 weeks of gestation).
Key Trial Info
Start Date :
October 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
958 Patients enrolled
Trial Details
Trial ID
NCT04063150
Start Date
October 6 2019
End Date
March 25 2020
Last Update
May 18 2022
Active Locations (1)
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1
icddr,b study clinics (Mirpur and CTU Dhaka)
Dhaka, Bangladesh