Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Polio, Inactivated polio vaccine, IPV, oral polio vaccine
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- Mirpur clinic (International Center for Diarrhoeal Disease Research, Bangladesh)
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Arm A
Arm B
Arm C
Group A will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group A participants will also receive inactivated polio vaccine (IPV) at 6 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.
Group B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group B participants will also receive inactivated polio vaccine (IPV) at 14 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.
Group C will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group C participants will also receive inactivated polio vaccine (IPV) at 6 and 14 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.