Immunogenicity of Inactivated and Live Polio Vaccines
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Polio, Inactivated polio vaccine, oral polio vaccine, vaccine trial
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 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)
Sites / Locations
- Mirpur Health Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Group A: Trivalent Oral Polio Vaccine
Group B: Bivalent Oral Polio Vaccine
Group C: Inactivated Polio Vaccine
Group D: fractional IPV (f-IPV)
Arm E: f-IPV and bOPV
Group A will receive 3 doses of trivalent oral polio vaccine (tOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV 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. A challenge dose of tOPV will be administered at 18 weeks of age.
Group C will receive 2 doses of inactivated polio vaccine (IPV) at 6 and 14 weeks of age. IPV will be administered intramuscularly using standard needle and syringe. A challenge dose of tOPV will be administered at 18 weeks of age.
Group D will receive 2 doses of fractional inactivated polio vaccine (f-IPV) at 6 and 14 weeks of age. f-IPV (one-fifth dose of IPV) will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
Group E will receive 2 doses of f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age. f-IPV will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.