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Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

NCT05116241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2025-11-06

Study results available
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Summary

This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.

Conditions

  • Bordetella Pertussis, Whooping Cough

Interventions

BIOLOGICAL

BPZE1 pertussis vaccine and placebo

Live attenuated pertussis vaccine and placebo

BIOLOGICAL

BPZE1 pertussis vaccine and Boostrix

Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine

BIOLOGICAL

Placebo and Boostrix

Tetanus, diphtheria, and aP vaccine and placebo

Sponsors & Collaborators

  • ILiAD Biotechnologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2024-05-15
Completion
2024-05-15
FDA Drug
Yes

Countries

  • Australia
  • Costa Rica
  • United Kingdom

Study Locations

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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 NCT05116241 on ClinicalTrials.gov