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Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

NCT05644184 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2232

Last updated 2026-01-09

No results posted yet for this study

Summary

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)

Drop counts of nOPV vaccine will be varied to achieve approximately 10\^5.5, 10\^6.0, 10\^6.5 CCID50 or 10\^7.0, 10\^7.5 dose levels.

BIOLOGICAL

Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)

The Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 control and challenge vaccine (mOPV1) contains ≥ 10\^6.0 CCID50 per 0.1 mL (2 drops) dose.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • PT Bio Farma

    collaborator INDUSTRY

  • Centers for Disease Control and Prevention

    collaborator FED

  • DiagnoSearch Life Sciences Pvt. Ltd.

    collaborator UNKNOWN

  • PATH

    lead OTHER

Principal Investigators

  • K. Zaman, MBBS, MPH, PhD, FRCP · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
0 Days
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-27
Primary Completion
2026-05-15
Completion
2026-05-15

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 NCT05644184 on ClinicalTrials.gov