Risk of Febrile Convulsions after a Second Immunization against Measles, Mumps and Rubella with MMRV as compared to MMR or MMR+V (MMRV 2nd dose)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29012
• EU PAS number:
  EUPAS5899
• Study ID:
  29012
• Official title and acronym:
  Risk of Febrile Convulsions after a Second Immunization against Measles, Mumps and Rubella with MMRV as compared to MMR or MMR+V (MMRV 2nd dose)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The German Standing Vaccination Committee (STIKO) recommends vaccination against measles, mumps, rubella (MMR), and varicella (V) in all children at 11 to 14 months of age (1st dose) and revaccination at 15 to 23 months of age (2nd dose). In July 2006, the combined measles-mumps-rubella-varicella (MMRV) vaccine Priorix-Tetra® (GlaxoSmithKline) was licensed in Germany, which made simultaneous vaccination against all four infectious diseases possible. After licensure of the MMRV vaccine, studies on the safety of the vaccine have suggested an elevated risk for febrile convulsions (FC) in children vaccinated with a 1st dose of MMRV as compared to children vaccinated with separately administered MMR and V vaccines. Concerning the risk of FC after the 2nd dose of MMRV as compared with a 2nd dose of MMR or MMR+V, data was generally limited and no information was available for Germany, where the 2nd dose is recommended for relatively young children as compared to e.g. the US (recommendation for 2nd dose at the age 4 to 6 years). A retrospective matched cohort study was performed on the basis of statutory health insurance claims data from 2004 to 2008. For the determination of the risk of febrile seizures after administration of the 2nd dose of vaccination against measles, mumps and rubella (two doses are recommended at age 11-14 and 15-23 months in Germany), a total of 159,013 children were included in the study, of whom 50,350 (32%) had received the MMRV vaccine. Due to very low incidences of FC in the risk intervals under investigation, the power of the analyses was insufficient to draw reliable conclusions from the generated results and to exclude a risk of FC. Further analyses based on a larger sample size are planned.
• 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: 26/03/2013

Actual: 03/04/2013

Study start date

Planned: 01/01/2004

Actual: 01/01/2004

Data analysis start date

Planned: 01/04/2013

Actual: 01/04/2013

Date of final study report

Planned: 31/07/2013

Actual: 29/07/2013

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)?:
  Not applicable