Immunogenicity of Monovalent Type 2 Oral Poliovirus Vaccine
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Polio, Inactivated polio vaccine, oral polio vaccine, monovalent type 2 oral polio vaccine
Eligibility Criteria
Inclusion Criteria:
- Infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study.
- Parents that are able to understand and comply with planned study procedures.
Exclusion Criteria:
- Parents and infants who are unable to participate in the full length of the study.
- Evidence of a chronic medical condition identified during physical exam.
- 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 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV or IPV 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
- International Center for Diarrhoeal Disease Research, Bangladesh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
mOPV2 at 6 and 7 weeks of age
mOPV2 at 6 and 8 weeks of age
mOPV2 at 6 and 10 weeks of age
mOPV2 at 6 and 10 week of age and IPV at 6 weeks of age
Participants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 7 weeks of age
Participants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 8 weeks of age
Participants enrolled in this arm would receive a dose of monovalent type 2 oral polio vaccine (mOPV2) at 6 and 10 weeks of age
Participants enrolled in this arm would receive a dose monovalent type 2 oral polio vaccine (mOPV2) at 6 and 10 weeks of age. In addition, the participants will also receive inactivated polio vaccine (IPV) at 6 weeks of age