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Clodivac booster in healthy adults
NCT05480462Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2022
- Primary completion
- Mar 2024
- Countries
- 1
- Sponsor
- IBSS Biomed S.A.
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- Tetanusdiphtheria
01
Overview
Phase 3, randomised, single-blind trial of tetanus toxoid + diphtheria toxoid in Tetanus and diphtheria (2 arms), sponsored by IBSS Biomed S.A. Primary endpoint: Seroconversion Rate at 28 days. Started Dec 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Clodivac
Experimental arm receiving one dose of Clodivac.
Td-Impfstoff Merieux
Active comparator arm receiving one dose of Td-Impfstoff Merieux.
03
Who it enrols
Healthy adults aged 18-65 with a history of diphtheria and tetanus vaccination (4-16 years prior).
04
Endpoints
Primary
Seroconversion Rate
Secondary
Ratio of Geometric Mean Concentrations
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