Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03998215

Enrollment

Registered

2019-06-26

Start date

2012-12-01

Completion date

2015-01-01

Last updated

2019-06-26

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

Conditions

Diphtheria, Inflammatory Bowel Diseases

Brief summary

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

Interventions

BIOLOGICALDiphtheria booster vaccination

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Achieving seroprotective antibody concentration	after 4-8 weeks	Antibody concentrations ≥0.1 IU/ml indicated protection against diphtheria, while levels ≥1.0 IU/ml were considered to ensure long-term protection.

Secondary

Measure	Time frame	Description
Booster response	after 4-8 weeks	Booster response was defined as a post-vaccination antibody concentration ≥0.4 IU/mL in initially seronegative subjects or as a fourfold increase of antibody concentration in initially seropositive ones.
Adverse effects	3 days	Evaluation of adverse effects after vaccination.
Inflammatory bowel disease exacerbation occurrence.	after 4-8 weeks	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026