Status:
COMPLETED
Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Poliomyelitis
Eligibility:
All Genders
6-7 years
Phase:
PHASE3
Brief Summary
This study will be an open-label phase III randomized clinical trial comparing different combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV administered at 6 ...
Detailed Description
Oral poliovirus vaccines are live attenuated viral vaccines and the vaccine virus in OPV can mutate and acquire neurovirulence causing paralysis either due to vaccine-associated paralytic polio (VAPP)...
Eligibility Criteria
Inclusion
- Healthy infants 6-7 weeks of age
- Family that consents for participation in the full length of the study
- Family that is able to understand and comply with planned study procedures
Exclusion
- Family that is 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 diarrhea, infection or illness at the time of enrollment (6-7 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age)
- Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall
- Known allergy/sensitivity or reaction to polio vaccine or contents of polio vaccine
- Infants from multiple births. Infants from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The infant(s) from a multiple birth who is/are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant
- Infants from premature births (\<37 weeks of gestation)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT02291263
Start Date
October 1 2014
End Date
August 1 2015
Last Update
August 27 2015
Active Locations (1)
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1
Mirpur clinic (International Center for Diarrhoeal Disease Research, Bangladesh)
Dhaka, Bangladesh