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dTap booster vaccination of health care workers (HC dTap)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511478-56-00
Enrollment
100
Registered
2024-04-24
Start date
2024-05-03
Completion date
Unknown
Last updated
2024-04-24

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

Conditions

Diphtheria, tetanus, pertussis (wooping cough)

Brief summary

The percentage of study participants with PT-specific IgG antibody geometric mean concentration (GMC) ≥5 IU/mL 0-7 days pre-vaccination.

Detailed description

PT-specific IgG antibody geometric mean concentration (GMC) 28 days after vaccination., The difference in FHA, PRN, and Fimbriae 2/3 IgG antibody GMCs pre- and 28 days post-vaccination., Pertussis antigen-specific plasma B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot., Pertussis antigen-specific memory B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot., Pertussis antigen-specific T-cell responses determined by cytokine analysis either from pertussis antigen stimulated whole blood samples/PBMC’s and/or supernatants., Assays measuring pertussis specific functional immunity include: PT neutralization; PT epitope specific antibodies; avidity; adherence inhibition; bactericidal activity; bacterial opsonization and phagocytosis undertaken on serum samples taken pre- and 28 days post-vaccination., Tetanus- and diphtheria toxoid-specific IgG antibody GMC measured by ELISA pre- and 28 days post-vaccination.

Interventions

DRUGTriaxis injektioneste
DRUGesitäytetty ruisku. Kurkkumätä
DRUGjäykkäkouristus ja hinkuyskä (soluton
DRUGkomponentti) -rokote (adsorboitu
DRUGvähennetty antigeeni(en) pitoisuus)

Sponsors

Varsinais-Suomen hyvinvointialue
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The percentage of study participants with PT-specific IgG antibody geometric mean concentration (GMC) ≥5 IU/mL 0-7 days pre-vaccination.

Secondary

MeasureTime frame
PT-specific IgG antibody geometric mean concentration (GMC) 28 days after vaccination., The difference in FHA, PRN, and Fimbriae 2/3 IgG antibody GMCs pre- and 28 days post-vaccination., Pertussis antigen-specific plasma B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot., Pertussis antigen-specific memory B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot., Pertussis antigen-specific T-cell responses determined by cytokine analysis either from pertussis antigen stimulated whole blood samples/PBMC’s and/or supernatants., Assays measuring pertussis specific functional immunity include: PT neutralization; PT epitope specific antibodies; avidity; adherence inhibition; bactericidal activity; bacterial opsonization and phagocytosis undertaken on serum samples taken pre- and 28 days post-vaccination., Tetanus- and diphtheria toxoid-specific IgG antibody GMC measured by ELISA pre- and 28 days post-vaccination.

Countries

Finland

Outcome results

None listed

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