A phase 4, randomised vaccination study in healthy adults to investigate the effects of acellular pertussis vaccine on colonisation with Bordetella pertussis using controlled human infection (KIM-study)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508416-35-00

Acronym

PaNaMa ID: 114794

Enrollment

Registered

2024-06-04

Start date

2024-10-16

Completion date

Unknown

Last updated

2026-01-26

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

Conditions

Pertussis or 'whooping cough'

Brief summary

Bp colonisation rate in Tdap-IPV and Td-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge, Bp colonisation rate in Tdap-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge

Interventions

DRUGAzitromycine 500 mg Teva

DRUGfilmomhulde tabletten.

DRUGREVAXIS Suspensie voor injectie in voorgevulde spuit. Difterie

DRUGtetanus en poliomyelitis (geïnactiveerd) vaccin

DRUGgeadsorbeerd

DRUGbeperkte hoeveelheid antigen(en).

DRUGREPEVAX

DRUGsuspension for injection

DRUGin pre-filled syringe Diphtheria

DRUGTetanus

DRUGPertussis (acellular

DRUGcomponent) and Poliomyelitis (inactivated) Vaccine (adsorbed

DRUGreduced antigen(s) content)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Bp colonisation rate in Tdap-IPV and Td-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge, Bp colonisation rate in Tdap-IPV vaccination groups, with Bp colonisation defined as any positive Bp culture from nasal wash samples at any time point between Day 3 and Day 28 after challenge	—

Countries

Netherlands

Outcome results

None listed

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