Risk of Febrile Convulsions after 1st dose MMRV vaccination in comparison to MMR and MMR+V vaccination (MMRV 1st 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 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.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  286622

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 febrile convulsion after a first dose of Priorix-Tetra™ (MMRV) compared to MMR and MMR+V in pre-defined risk intervals according to the number of days after immunization (0-4, 5-12, 13-30, and the entire risk period (0-30)).Children born between 01.01.2004 and 31.12.2008 who received a first dose of MMRV were matched to children vaccinated with MMR, MMR+V and MMR or MMR+V, by sex, age, month of vaccination and health insurance provider.Cumulative incidences (=risks) of primary and secondary outcomes with 95% CIs were calculated for all exposure groups within each risk interval. Risk ratios and risk differences of the primary and secondary outcomes were calculated with 95% CIs. Confounder adjusted odds ratios with corresponding 95% CIs were estimated to compare the MMRV exposure group with each of the comparison exposure groups using a separate binary logistic regression model for each risk interval.

Documents

Study results

ShortReport_FCHistory_v1.1

Study_Summary_v1_0

Study publications

Schink T, Holstiege J, Kowalzik F, Zepp F, Garbe E. Risk of febrile convulsions…