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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BD54) measles, combinations with mumps, rubella and varicella, live attenuated

  measles, combinations with mumps, rubella and varicella, live attenuated
• Medical condition to be studied:
  Febrile convulsion

Population studied

• Short description of the study population:
  All insurants born during the study period from January 1st, 2004 through December 31st, 2008, with available date of birth who received a 2nd vaccination with one of the index vaccines measles-mumps-rubella-varicella (MMRV), MMR+V, or MMR.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  159013

Study design details

• Main study objective:
  The objective of this study was to estimate the risk of febrile convulsions after a first dose vaccination with Priorix-Tetra® in comparison to first dose vaccination with MMR or MMR+V 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.
• Outcomes:
  The primary outcome of this study was the occurrence of febrile convulsions (FC) defined as hospitalization with a diagnosis of FC without any alternative plausible cause of FC, e.g. an infection or neurological condition, coded as main discharge diagnosis. The secondary outcome was defined as closely as possible to the outcome-criteria specified by the previous study by Jacobsen et al. That is, only hospitalizations for FC with a neurological condition coded as main discharge diagnosis were excluded.
• Data analysis plan:
  A retrospective matched cohort study was performed to provide risk estimates of FC after a 2nd dose of MMRV compared to MMR and MMR+V (index vaccines) in pre-defined risk intervals (RI). Insurants born from 01/01/2004 through 31/12/2008 who received a 2nd vaccination with one of the index vaccines were included in the cohort. Cumulative incidences were calculated. . Relative risks and risk differences for the comparison of exposure groups were calculated with 95% CIs. All children with a 2nd immunization with MMRV were matched 1:1 to children with a 2nd immunization with MMR or MMR+V by statutory health insurance, sex, age in months (± 1 month) and month of cohort entry (± 1 month).Multivariable analyses were performed, adjusted for FC history, hospitalization for an infectious disease, administration of other vaccines, type of 1st dose vaccine, time between 1st and 2nd dose to estimate ORs with 95% CIs using a separate binary logistic regression model for each RI.

Documents

Study results

Abstract