Status:
COMPLETED
Clinical Trial of Novel OPV2 Vaccine
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
Conditions:
Poliomyelitis
Eligibility:
All Genders
1-3 years
Phase:
PHASE2
Brief Summary
Though OPV is safe and effective, it can mutate and reacquire neurovirulence in rare circumstances. This can result in vaccine-associated paralytic polio and circulating vaccine-derived polioviruses. ...
Detailed Description
Burden: Oral Polio Vaccine (OPV) contains attenuated (weakened) polioviruses. Though OPV is safe and effective, it can mutate and reacquire neurovirulence in rare circumstances. This can result in vac...
Eligibility Criteria
Inclusion
- Newborns at birth (range: 0-3 days of age).
- Mothers that consent for participation in the full length of the study.
- Mothers those are able to understand and comply with planned study procedures.
Exclusion
- Mother and newborns who are unable to participate in the full length of the study.
- A diagnosis or suspicion of immunodeficiency disorder either in the newborn or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate collection of blood by venipuncture.
- Acute diarrhea, infection or illness at the time of enrollment that would require admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit.
- Receipt of any polio vaccine (OPV or IPV) and Rotavirus Vaccine (RVV) before enrollment based upon documentation or mothers recall.
- Newborns from multiple births. Newborns from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The newborn from a multiple birth who is /are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Newborns from premature births (\<37 weeks of gestation).
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04693286
Start Date
September 21 2020
End Date
August 30 2021
Last Update
August 30 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
: International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212