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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)

NCT06748612 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1190

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Pentavalent vaccine

Whole-cell pertussis pentavalent vaccine (wP-Penta): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus influenzae type b conjugate

BIOLOGICAL

Hexavalent vaccine

Whole-cell pertussis hexavalent vaccine (wP-Hexa): Each 0.5 ml dose contains diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen, Haemophilus influenzae type b conjugate, and inactivated polioviruses to all three poliovirus types: type 1 , 2 and 3

BIOLOGICAL

Inactivated poliovirus vaccine (IPV)

one dose of IPV (0.5 mL) contains inactivated polioviruses to all three poliovirus types: type 1, 2 and 3

BIOLOGICAL

Bivalent oral polio vaccine (bOPV)

Contain two poliovirus types: type 1 and 3

BIOLOGICAL

Fractional IPV( fIPV)

The dose of fIPV is 0.1 mL or 1/5th of a full dose

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
42 Days
Max Age
48 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2027-12-30
Completion
2027-12-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748612 on ClinicalTrials.gov