Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
BPZE1 intranasal pertussis vaccine in school-age children
NCT05116241Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2021
- Primary completion
- May 2024
- Countries
- 3
- Sponsor
- ILiAD Biotechnologies
- Modality
- Live Biotherapeutic Products, Vaccines & Immunotherapeutics
- Drugs
- BPZE1
- Conditions
- pertussis
01
Overview
Phase 2, randomised, double-blind trial in pertussis comparing BPZE1 + Placebo, BPZE1 + Boostrix and Placebo + Boostrix (3 arms). Primary endpoints: Geometric Mean Fold Rise of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at 29 days and Solicited Adverse Events at 7 days. Started Nov 2021; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
BPZE1 + Placebo
Intranasal BPZE1 and intramuscular placebo
BPZE1 + Boostrix
Intranasal BPZE1 and intramuscular Boostrix
Placebo + Boostrix
Intranasal placebo and intramuscular Boostrix (active comparator)
03
Who it enrols
Healthy school-age children aged 6-17 years without recent pertussis vaccination or infection, no chronic illnesses, no immunocompromised household contacts, and no infants under 6 months in household
04
Endpoints
Primary
Geometric Mean Fold Rise of Mucosal Immunogenicity S-IgA Against Whole Cell Extract
Solicited Adverse Events
Secondary
Proportion of Subjects With Antibody Concentration ≥0.1 for Diphtheria and Tetanus
Serum IgG Geometric Mean Concentration Against Acellular Pertussis Antigens
Mucosal Immunogenicity S-IgA Geometric Mean Ratio
Mucosal Immunogenicity S-IgA Geometric Mean Fold Rise
Serum Immunogenicity IgA and IgG Geometric Mean Concentration
Serum Immunogenicity IgA and IgG Geometric Mean Fold Rise
Reactogenicity and Adverse Events
Colonization
Beyond the preview
Go deeper on NCT05116241.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05116241.