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Tolerability, Safety, and Efficacy of Varicella-zoster-virus vaccination in immunosuppressed children with inflammatory bowel disease or autoimmunhepatitis

Tolerability, Safety, and Efficacy of Varicella-zoster-virus vaccination in immunosuppressed children with inflammatory bowel disease or autoimmunhepatitis - VARICED

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016357
Enrollment
366
Registered
2019-01-15
Start date
2013-11-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

K50.1 K51.0 K51.2 K51.3 K50.88 K51.9 K75.4

Interventions

Group 1: Vaccinations with varicella vaccine with documentation of side effects by questionnaires and assessment of effectivity by increment of specific antibodies.

Sponsors

Klinik für Kinder- und JugendmedizinUniversitätsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: As this is an observational study no inclusion criteria are defined. In principal, patients with chronic inflammatory bowel disease or autoimmune hepatitis being in steady state of their disease and having the indication of varicella vaccination due to insufficient protection against varicella can participate.

Exclusion criteria

Exclusion criteria: As this is an observational study no exclusion criteria are given for this study. Basically the recommendations from the enclosed leaflet have to be followed. In addition, we made some recommendations in our observational protocol. 1) We need a parent or patient consent to collect and analyze the data in this study. 2) If the patient is suspicious for an immunodeficiency this should be clarified first. 3) In addition to the leaflet we do not recommend immunization during an active underlying disease 4) Furthermore, we specified some conditions that may affect safety and efficiency, which should be avoided. In detail these conditions are stated in the observational protocol.

Design outcomes

Primary

MeasureTime frame
Safety of varicella vaccination using the immunological check list

Secondary

MeasureTime frame
Effectivity of vaccination with increment of vaccine specific antibody formation after 12-16 weeks

Countries

Germany

Contacts

Public ContactCarsten Posovszky

Klinik für Kinder- und JugendmedizinUniversitätsklinikum Ulm

carsten.posovszky@uniklinik-ulm.de0731-50057330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026