Status: Finalised First registered on: 24/02/2014
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS5899
Official titleRisk of Febrile Convulsions after a Second Immunization against Measles, Mumps and Rubella with MMRV as compared to MMR or MMR+V.
Study title acronymMMRV 2nd dose
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?Yes: Germany
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.eu
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/03/201303/04/2013
Start date of data collection01/01/200401/01/2004
Start date of data analysis01/04/201301/04/2013
Date of interim report, if expected
Date of final study report31/07/201329/07/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline Biologicals SA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)49-421-21856860 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Gerds 
First name Heike 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany 
Phone number (incl. country code)49-421-21856860 
Alternative phone number 
Fax number (incl. country code) 
Email address gepard@leibniz-bips.de 
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