Risk of Febrile Convulsions after 1st dose MMRV vaccination in comparison to MMR and MMR+V vaccination (MMRV 1st dose)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28996
• EU PAS number:
  EUPAS5896
• Study ID:
  28996
• Official title and acronym:
  Risk of Febrile Convulsions after 1st dose MMRV vaccination in comparison to MMR and MMR+V vaccination (MMRV 1st dose)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  In July 2006, Priorix-Tetra™, a combined measles-mumps-rubella-varicella (MMRV) vaccine, was licensed in Germany. Since a post-licensure study (Jacobsen et al., 2009) had shown a more than twofold elevated risk of febrile convulsions (FC) after first dose vaccination with the combined MMRV vaccine ProQuad® compared to separately administered MMR and V vaccines (MMR+V), a study investigating the risk of FC for Priorix-Tetra™ was requested by the Paul-Ehrlich Institute, the regulatory agency responsible for vaccine licensing and safety in Germany.A retrospective matched cohort study was performed to provide risk estimates of FC after a first dose of Priorix-Tetra™ (MMRV) compared to MMR and MMR+V in pre-defined risk intervals. All children born between 01.01.2004 and 31.12.2008 who received a first dose of MMRV vaccine were matched to children vaccinated with MMR, MMR+V and MMR or MMR+V, respectively, by sex, age, month of vaccination and statutory health insurance provider.The objective of this study was to estimate the risk of FC after a first dose vaccination with Priorix-Tetra™ compared to first dose vaccination with MMR or MMR+V vaccines in the pre-specified risk intervals: 0-4 days after immunization, 5-12 days after immunization (main risk interval), 13-30 days after immunization, and the entire risk period, that is 0-30 days after immunization.
• Study status:
  Finalised

Research institutions and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Study timelines

Date when funding contract was signed

Planned: 14/01/2011

Actual: 14/01/2011

Study start date

Planned: 01/01/2004

Actual: 01/01/2004

Data analysis start date

Planned: 14/01/2011

Actual: 14/01/2011

Date of final study report

Planned: 30/09/2011

Actual: 14/03/2012

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals SA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)