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Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults

NCT03942406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-06-27

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 a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost.

Conditions

Interventions

COMBINATION_PRODUCT

BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • ILiAD Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Mary B Manning, MD · Rapid Medical Research Inc

  • Barbara Rizzardi, MD · Advanced Clinical Research Services, LLC

  • Vicki Miller, MD · DM Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2020-02-14
Completion
2020-06-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03942406 on ClinicalTrials.gov