De effectiviteit van het hepatitis B vaccin bij kinderen geboren uit moeders met een inflammatoire darmziekte die anti-TNF hebben gebruikt tijdens de zwangerschap

Recruiting

• Conditions: Hepatitis B vaccineChildren born to IBD mothersInflammatory Bowel DiseaseAnti-TNF

• Registration Number: NL-OMON20411
• Lead Sponsor: Erasmus University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Study group: children born to IBD mothers treated with anti-TNF (infliximab or adalimumab) during (part of) the pregnancy

- Control group: children born to IBD mothers not treated with anti-TNF (any other IBD medication)

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

- incapacity to understand the informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anti-HBs levels 4 weeks after last inoculation for HBV

Secondary Outcome Measures

Name	Time	Method
(if required) anti-HBs levels after HBV booster vaccine in case of primary non-immunity