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Maternal determinants of infant immunity to pertussis (MADI-02)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517893-73-00
Enrollment
240
Registered
2024-10-16
Start date
2023-09-09
Completion date
2025-12-23
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whooping cough

Brief summary

The magnitude of the antibody responses to pertussis vaccination

Detailed description

Subclass and binding of pertussis-specific antibodies to Fc-receptors, complement and lectin-like receptors post vaccination., Functional antibody profiling post vaccination (including assays covering cytotoxicity, phagocytosis, cytokine production, antigen uptake), Antibody and B cell repertoire post vaccination, The magnitude and quality of Tdap-specific T lymphocytes post vaccination

Interventions

DRUGVaxelis suspension for injection in pre-filled syringe Diphtheria
DRUGtetanus
DRUGpoliomyelitis (inactivated)
DRUGand Haemophilus type b conjugate vaccine (adsorbed).
DRUGsuspension injectable en seringue préremplie. Vaccin diphtérique
DRUGtétanique et coquelucheux (acellulaire) (adsorbé
DRUGcontenu réduit en antigène(s))

Sponsors

Universite Libre de Bruxelles
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The magnitude of the antibody responses to pertussis vaccination

Secondary

MeasureTime frame
Subclass and binding of pertussis-specific antibodies to Fc-receptors, complement and lectin-like receptors post vaccination., Functional antibody profiling post vaccination (including assays covering cytotoxicity, phagocytosis, cytokine production, antigen uptake), Antibody and B cell repertoire post vaccination, The magnitude and quality of Tdap-specific T lymphocytes post vaccination

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026