Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-01

Study Completion Date

2015-01-01

Brief Summary

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

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Detailed Description

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Conditions

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Diphtheria Inflammatory Bowel Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diphtheria booster vaccination

One booster dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

Group Type EXPERIMENTAL

Diphtheria booster vaccination

Intervention Type BIOLOGICAL

Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

Interventions

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Diphtheria booster vaccination

Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
* vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No