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Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine

NCT05460377 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1224

Last updated 2025-03-19

No results posted yet for this study

Summary

This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS

The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe.

BIOLOGICAL

Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS

The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe.

BIOLOGICAL

Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP

The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe

BIOLOGICAL

Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP

The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe

Sponsors & Collaborators

Principal Investigators

  • Khalequ Zaman, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2023-07-22
Completion
2024-12-01

Countries

  • Bangladesh

Study Locations

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Entities

Companies

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 NCT05460377 on ClinicalTrials.gov