ClinicalTrials.gg
Sign In
CompletedNCT03998449Updated May 20, 2020

Immunogenicity of Cholera Vaccine in Children With IBD

An interventional study of Vaccination against cholera in Cholera and Inflammatory Bowel Diseases, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Aug 2017, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
6 Years to 18 Years
Sex
All
01

Study summary

Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.

02

Conditions studied

  • Cholera
  • Inflammatory Bowel Diseases
03

In context

Cholera

79 studies on the registry are indexed under Cholera; 11 are open to participants now.

This study's enrollment of 80 is below the median of 292 across 68 interventional studies indexed under Cholera.

Browse Cholera studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Browse Medical University of Warsaw studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
  • no vaccination against cholera in the past,
  • written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion criteria

Exclusion Criteria:

  • serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Cholera vaccination

    Two doses of the vaccine against cholera

    Biological: Vaccination against cholera

Interventions

  • BiologicalVaccination against cholera

    Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.

06

What researchers measure

Primary outcomes

  1. Achieving seroprotective antibody concentration

    Serum antibody concentration indicating protection against cholera.

    Time frame: 4-6 weeks after the second dose

Secondary outcomes

  1. Adverse effects

    Evaluation of adverse effects after vaccination.

    Time frame: 3 days after each dose

  2. Inflammatory bowel disease exacerbation occurrence.

    Disease exacerbation assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.

    Time frame: 4-6 weeks after the second dose

07

Study locations

1 site
  • Medical University of Warsaw
    Warsaw, 02-091, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Apr 2020, 31 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2019
First posted
Jun 26, 2019
StartActual
Aug 30, 2017
Primary completionActual
Apr 1, 2020
CompletionActual
May 1, 2020
Last update
May 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03998449
Lead sponsor
Medical University of Warsaw
Collaborators
Medical University of Gdansk
Responsible party
Lukasz Dembinski (Principal Investigator, Medical University of Warsaw) — Principal investigator
First posted
Jun 26, 2019
Start date
Aug 30, 2017
Primary completion
Apr 1, 2020
Completion
May 1, 2020
Last update
May 20, 2020

Study contacts

Aleksandra Banaszkiewicz, MD, PhD
study director · Medical University of Warsaw

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cholera →

Other studies from this sponsor

Medical University of Warsaw →

Start the discussion