Immunogenicity of Different Primary Immunization Schedules with Inactivated Poliovirus Vaccine (IPV) Plus Pentavalent Vaccine (DTwP-HBV-Hib) or with Hexavalent Vaccine (DTwP-HBV-Hib-IPV)

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Dec 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well different vaccination schedules using the inactivated poliovirus vaccine (IPV) work when given alongside either a pentavalent vaccine or a hexavalent vaccine in infants. The main goal is to see how many infants develop immunity to polio after receiving these vaccines and to understand how long that immunity lasts. The study will include healthy infants who are around 6 weeks old, and their parents will need to agree to participate for the entire duration of the trial.

Participants will receive vaccinations, and researchers will take blood samples to check how their immune systems respond to the vaccines over time. They will also assess if these vaccines provide enough protection against the polio virus. To take part in the study, infants must be healthy and not have any serious medical conditions that could interfere with the vaccinations. If you're considering participation, you and your child will need to be available for the study's full length, and it's important to follow the planned procedures. This trial aims to provide valuable information that can help improve polio vaccination programs, especially in countries like Bangladesh.

Gender

ALL

Eligibility criteria

• • A. Assessment of seroprotection and safety of wP-Hexa with primary immunization schedules.
• Inclusion Criteria:
• • 1. Healthy infants 6 weeks of age (range: 42-48 days).
• • 2. Parents that consent for participation in the full length of the study.
• • 3. Parents that can understand and comply with planned study procedures.
• Exclusion Criteria:
• • 1. Parents and infants are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
• • 2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• • 3. A diagnosis or suspicion of bleeding disorder that would contraindicate administration of IPV, wP Penta or wP-Hexa, or collection of blood by venepuncture.
• • 4. Acute diarrhoea, infection, or illness at the time of first study vaccination that would require infant's admission to a hospital.
• • 5. Acute vomiting and intolerance to liquids within 24 hours before the first study vaccination.
• • 6. Any encephalopathy of unknown origin occurring within 7 days following previous vaccination with any pertussis containing vaccine.
• • 7. Uncontrolled neurologic disorder or uncontrolled epilepsy (Pertussis vaccine should not be administered to individuals with these conditions until the treatment regimen has been established and the condition has stabilized).
• • 8. Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• • 9. Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
• • 10. Known allergy/sensitivity or reaction to polio, pertussis, tetanus, diphtheria, hepatitis B, Hib vaccines or its contents.
• • 11. Infants from multiple births. This exclusion is done because the non-participant infant will likely receive OPV through routine immunization and may transmit vaccine poliovirus to the enrolled infant.
• • 12. Infants from premature births (\<37 weeks of gestation).
• B. Mucosal immunity against poliovirus sub-study :
• • Inclusion criteria
• * Participants:
• • Participants in study arms A and B who complete study procedures up to 18 months and whose parents do not request discontinuation
• * Controls:
• • Children aged 18 months who have received polio vaccination through routine immunization services verified by immunization card (bOPV at 6, 10 and 14 weeks; fIPV at 6 and 14 weeks)
• • Exclusion criteria
• • 1. Parents and infants are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
• • 2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• • 3. A diagnosis or suspicion of bleeding disorder that would contraindicate administration of bOPV or collection of blood by venepuncture.
• • 4. Acute diarrhoea, infection, or illness at the time of enrolment (18 months of age) that would require infant's admission to a hospital.
• • 5. Febrile disease that contraindicates administration of pentavalent vaccine (even if hospitalization is not required).
• • 6. Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (18 months of age).
• • 7. Known allergy/sensitivity or reaction to oral polio vaccines or its contents.
• • 8. Received any polio vaccines outside of the routine immunization schedule.
• • 9. Household members have received OPV within 1-2 months prior to enrolment.