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

HBV vaccine efficacy in children exposed to anti-TNF in utero

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20411

Enrollment

Registered

2014-04-15

Start date

2014-04-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Hepatitis B vaccine Children born to IBD mothers Inflammatory Bowel Disease Anti-TNF

Interventions

None listed

Eligibility

Inclusion criteria

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

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 - Maternal HBV, HCV or HIV infection - Other immune-compromising conditions in the child - Not intending to vaccinate child according to the Dutch National Vaccination Programme in Dutch: ‘Nederlandse Rijksvaccinatieprogramma’

Design outcomes

Primary

Measure	Time frame
anti-HBs levels 4 weeks after last inoculation for HBV	—

Secondary

Measure	Time frame
(if required) anti-HBs levels after HBV booster vaccine in case of primary non-immunity	—

Contacts

Public ContactA. Lima, de

Erasmus MC

a.delima@erasmusmc.nl

Outcome results