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 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: PR-24093
• Study Type: interventional
• Target: 1,190
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To compare the proportion of participants who seroconvert to all poliovirus serotypes four weeks after a primary immunization series.
2. 2.To compare the proportion of participants seropositive against all poliovirus serotypes at 18 months of age.

Conditions

Polio

Outcome Measures

Primary Outcomes (2)

• 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

  Seroconversion will be defined as seronegative participants (\<1:8 titers) becoming seropositive (≥1:8) or seropositive participants with ≥ 4-fold increase in titers between pre vaccination and four weeks after the third vaccine dose (adjusted for the expected decline of maternal antibodies). For assessing immunity to polio, seropositivity is defined as reciprocal polio neutralizing antibody titers of at least 1:8. Baseline maternally-related antibody titers will be determined in the pre-vaccination sample and estimated maternal antibody level after the vaccination series will be calculated assuming an exponential decline with a half-life of 28 days

  Arm A: 14 weeks and 10 months , Arm B: 6 and 18 weeks , Arm C: 2 and 7 months

• 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).

  Seroconversion will be defined as seronegative participants (\<1:8 titers) becoming seropositive (≥1:8) or seropositive participants with ≥ 4-fold increase in titers between pre vaccination and four weeks after the third vaccine dose (adjusted for the expected decline of maternal antibodies). For assessing immunity to polio, seropositivity is defined as reciprocal polio neutralizing antibody titers of at least 1:8. Baseline maternally-related antibody titers will be determined in the pre-vaccination sample and estimated maternal antibody level after the vaccination series will be calculated assuming an exponential decline with a half-life of 28 days

  18 months for all study arms

Secondary Outcomes (1)

• Proportion of participants with seroprotection/vaccine response for non-polio antigens (Pertussis, Hepatitis B, Diphtheria, Tetanus) contained in wP-Hexa or wP-Penta four weeks after the last dose of wP-Hexa or wP-Penta

  6 and 18 weeks for A and B; 2 and 7 months for C

Study Arms (4)

Arm A

EXPERIMENTAL

Arm A will receive wP-Penta at 6,10,14 weeks of age and 2 doses of IPV at 14 weeks and 9 months.

Biological: Pentavalent vaccine; Biological: Inactivated poliovirus vaccine (IPV)

Arm B

EXPERIMENTAL

Arm B will receive wP-Hexa at 6,10,14 weeks of age

Biological: Hexavalent vaccine

Arm C

EXPERIMENTAL

Arm C will receive wP-Hexa at 2,4,6 months of age.

Biological: Hexavalent vaccine

Control Arm

ACTIVE COMPARATOR

Control group will receive EPI schedule of routine immunization: fIPV @ 6, 14 wk, bOPV @ 6, 10, 14 wk , wP-Penta @ 6, 10, 14 wk

Biological: Pentavalent vaccine; Biological: Bivalent oral polio vaccine (bOPV); Biological: Fractional IPV( fIPV)

Interventions

Pentavalent vaccine BIOLOGICAL

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

Arm A; Control Arm

Hexavalent vaccine BIOLOGICAL

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

Arm B; Arm C

Inactivated poliovirus vaccine (IPV) BIOLOGICAL

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

Arm A

Bivalent oral polio vaccine (bOPV) BIOLOGICAL

Contain two poliovirus types: type 1 and 3

Control Arm

Fractional IPV( fIPV) BIOLOGICAL

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

Control Arm

Eligibility Criteria

• Age: 42 Days - 48 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 6 weeks of age (range: 42-48 days).
• Parents that consent for participation in the full length of the study.
• Parents that can understand and comply with planned study procedures.

You may not qualify if:

• 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).
• 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 administration of IPV, wP Penta or wP-Hexa, or collection of blood by venepuncture.
• Acute diarrhoea, infection, or illness at the time of first study vaccination that would require infant's admission to a hospital.
• Acute vomiting and intolerance to liquids within 24 hours before the first study vaccination.
• Any encephalopathy of unknown origin occurring within 7 days following previous vaccination with any pertussis containing vaccine.
• 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).
• Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
• Known allergy/sensitivity or reaction to polio, pertussis, tetanus, diphtheria, hepatitis B, Hib vaccines or its contents.
• Infants from premature births (\<37 weeks of gestation).
• B. Mucosal immunity against poliovirus sub-study :
• Participants:
• Participants in study arms A and B who complete study procedures up to 18 months and whose parents do not request discontinuation
• Controls:

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

MeSH Terms

Conditions

Poliomyelitis

Interventions

Vaccines, Combined; Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures; Vaccines, Inactivated; Poliovirus Vaccines; Viral Vaccines

Central Study Contacts

Khalequ Zaman, MBBS, MPH, PhD, FRCP Edin

CONTACT

+8801713047100; kzaman@icddrb.org

Concepcion F. Estivariz, PhD

CONTACT

Cell phone: (470) 312-5677; cge3@cdc.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 27, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share