Immunogenicity of Different Primary Immunization Schedules with Inactivated Poliovirus Vaccine (Iā¦ (NCT06748612) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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)
1,190 participantsStarted 2025-01-28
Plain-language summary
The goal of this study is to provide information on immunogenicity at short and medium term for hexavalent with different schedules, which will be useful for the global polio program and countries, including Bangladesh.
Primary objectives are
1. To compare the proportion of participants who seroconvert to all poliovirus serotypes four weeks after a primary immunization series.
2. To compare the proportion of participants seropositive against all poliovirus serotypes at 18 months of age.
This is an open-label randomized clinical trial. Participants will be enrolled and randomized at 6 weeks of age to one of three arms. Target enrolment is 330 infants per arm and 200 controls; 990 in the main study and \~ 800 in the sub-study.
A total of 4-5 blood samples will be collected from each infant before and after the primary vaccination series, and at 18 months of age, to assess systemic immune response to different antigens.
Outcome measures/variables:
Neutralizing antibody titers in serum will be quantified for poliovirus types 1, 2, and 3 using a microneutralization test; for diphtheria toxoid, tetanus toxoid, and pertussis toxin using a Multiplex bead assay; and for antibodies to hepatitis B surface antigen (anti-HBs) using serologic assay. The presence of poliovirus types 1 and 3 in oropharyngeal swabs and stools following the bOPV challenge will be tested using a real-time reverse transcription PCR (rRT-PCR) assay.
Who can participate
Age range42 Days ā 48 Days
SexALL
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Inclusion criteria
ā. Healthy infants 6 weeks of age (range: 42-48 days).
ā. Parents that consent for participation in the full length of the study.
ā. Parents that can understand and comply with planned study procedures.
Exclusion criteria
ā. 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).
ā. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
ā. A diagnosis or suspicion of bleeding disorder that would contraindicate administration of IPV, wP Penta or wP-Hexa, or collection of blood by venepuncture.
ā. Acute diarrhoea, infection, or illness at the time of first study vaccination that would require infant's admission to a hospital.
ā. Acute vomiting and intolerance to liquids within 24 hours before the first study vaccination.
ā
What they're measuring
1
Proportion of participants with seroconversion to all poliovirus serotypes four weeks after a primary immunization series with two doses of IPV or three doses of wP-Hexa
Timeframe: Arm A: 14 weeks and 10 months , Arm B: 6 and 18 weeks , Arm C: 2 and 7 months
2
Proportion of participants seropositive to all polio types at 18 months of age (9-14 months after the last dose of IPV for each schedule).
Timeframe: 18 months for all study arms
Trial details
NCT IDNCT06748612
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh
. Any encephalopathy of unknown origin occurring within 7 days following previous vaccination with any pertussis containing vaccine.
ā. 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).
ā. Evidence of a chronic medical condition identified by a study medical officer during physical exam.