Status:
COMPLETED
Immunogenicity of Inactivated and Live Polio Vaccines
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Ministry of Health and Family Welfare, Bangladesh
Conditions:
Poliomyelitis
Eligibility:
All Genders
6-7 years
Phase:
PHASE3
Brief Summary
This study is an open-label phase III randomized clinical trial that would compare immunogenicity after receiving one of five different combinations of polio vaccines. Infants will be enrolled and ran...
Detailed Description
Global polio eradication initiative (GPEI) In 1988, the World Health Assembly adopted the resolution of polio eradication by 2000. This launched the Global Polio Eradication Initiative (GPEI), spearh...
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 are excluded to reduce the potential for contact transmission of vaccine poliovirus. The infant from a multiple birth who is not enrolled is 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 :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
1206 Patients enrolled
Trial Details
Trial ID
NCT01813604
Start Date
November 1 2012
End Date
November 1 2013
Last Update
January 9 2014
Active Locations (1)
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1
Mirpur Health Clinic
Dhaka, Bangladesh