At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 300 enrolled
Drug / intervention
BPZE1 pertussis vaccine and VaxINator(TM) Atomization Devicecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2b Study of BPZE1 Intranasal Pertussis Vaccine in Adults to Assess Immunological Response and Safety Profile of 1-Dose (Prime) and 2-Doses (Prime+Boost) Schedule, Compared to a Boostrix™ Prime Dose With or Without a BPZE1 Boost Dose
In Brief
A Phase 2 clinical trial evaluating BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device for Pertussis and Whooping Cough. Completed, enrolled 300 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPertussis, Whooping Cough
CountriesUnited States
CollaboratorsPPD Development, LP
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJun 2019
Primary CompletionFeb 2020
Study CompletionJun 2020
TodayJul 2026
First PostedMay 8, 2019
Enrollment StartJun 15, 2019
Primary CompletionFeb 14, 2020
Study CompletionJun 24, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.1 years ago
Interventions
BPZE1 pertussis vaccine and VaxINator(TM) Atomization Devicecombination
Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device