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GMDS 2012: 57. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

16. - 20.09.2012, Braunschweig

Epidemiological study on febrile convulsions after first dose MMRV vaccination compared to first dose MMR or MMR+V vaccination

Meeting Abstract

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  • Tania Schink - BIPS – Universität Bremen, Deutschland
  • Jakob Holstiege - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland
  • Edeltraut Garbe - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland

GMDS 2012. 57. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Braunschweig, 16.-20.09.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. Doc12gmds176

DOI: 10.3205/12gmds176, URN: urn:nbn:de:0183-12gmds1767

Published: September 13, 2012

© 2012 Schink et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

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Background: In July 2006 a combined measles-mumps-rubella-varicella (MMRV) vaccine was licensed in Germany. A meta-analysis of clinical data suggested an increased risk of febrile convulsions (FC) in children who received a first dose of MMRV compared to children who received a first dose of measles-mumps-rubella (MMR) vaccine or MMR and V vaccine separately on the same day (MMR+V).

Objectives: To estimate the risk of FC after first dose vaccination with MMRV in comparison to vaccination with MMR or MMR+V in pre-specified time-windows.

Methods: We performed a matched cohort study based on claims data from four German statutory health insurance providers (SHIs) covering more than 14 million health insurance members in Germany. All insurants born in the study period (01.01.04 to 31.12.08) who received a first dose vaccination with one of the index vaccines (MMRV, MMR, MMR+V) were included in the cohort. Members of the MMRV group were matched individually to members of the MMR and MMR+V groups with respect to sex, age at immunization, calendar month of immunization and SHI. The primary endpoint was defined as hospitalization with a diagnosis of FC where no plausible cause of FC, e.g. an infection or neurological condition, was coded as main discharge diagnosis. The secondary endpoint excluded only FC hospitalizations where a neurological condition was coded as main discharge diagnosis. Confounder adjusted odds ratios (ORs) with 95% confidence intervals (95%-CIs) were estimated to compare the exposure groups using a binary logistic regression model for each risk interval.

Results: In the main risk period 5 to 12 days after immunization 18 cases of FC (primary endpoint) were observed among 82,531 MMRV-vaccinated children, ten cases were observed among 149,129 MMR-vaccinated children and two cases were observed among 39,164 MMR+V-vaccinated children. This resulted in adjusted ORs of 4.13 (95%-CI 1.34–12.68) for the comparison of MMRV with MMR and 3.53 (95%-CI 0.66–18.98) for the comparison with MMR+V. Regarding the secondary endpoint, 51cases were observed in the MMRV group, 50 cases were observed in the MMR group and 18 cases were observed in the MMR+V group. This resulted in adjusted ORs for the secondary endpoint of 2.30 (95%-CI 1.36–3.88) for the comparison with MMR and 1.52 (95%-CI 0.79–2.93) for the comparison with MMR+V.

Conclusions: This study suggests a 2- to 4-fold increase in the risk of FC in the interval 5 to 12 days after a first dose MMRV immunization compared to MMR immunization and a 1.5 to 3.5-fold increase compared to MMR+V immunization.