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Summary results from VSD- and Merck-sponsored studies for febrile seizure after the first dose of MMRV compared with the first dose of MMR and varicella vaccine administered at the same visit – United States, 2009

Summary results from VSD- and Merck-sponsored studies for febrile seizure after the first dose of MMRV compared with the first dose of MMR and varicella vaccine administered at the same visit – United States, 2009
Characteristic VSD Merck-sponsored
Age/No. subjects, by vaccine
  All aged 12 to 23 months 99% aged 12 to 23 months
MMRV: n = 83,107 MMRV: n = 31,298
MMR and varicella: n = 376,354 MMR and varicella: n = 31,298
Postvaccination interval
Week 1 to 2 7 to 10 days* 5 to 12 days*
RR: 2.0 (CI = 1.4-2.9) RR: 2.2 (CI = 1.0-4.7)
AR: 4.3 per 10,000 (CI = 2.6-5.6) AR: 3.8 per 10,000 (CI = 0.3-7.4)
Week 1 to 6 0 to 42 days* 0 to 30 days
RR: 1.5 (CI = 1.1-1.9) RR: 1.1 (CI = 0.7-1.7)
AR: 6.2 per 10,000 (CI = 2.0-9.5) AR: 1.3 per 10,000 (CI = –4.5-7.0)
VSD: Vaccine Safety Datalink; MMRV: measles, mumps, rubella, and varicella vaccine; MMR: measles, mumps, rubella vaccine; RR: relative risk; AR: attributable risk; CI: 95% confidence interval.
* Statistically significant at <0.05.
Data from:
  1. From Centers for Disease Control and Prevention. Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2010; 59:4.
  2. Klein NP, Fireman B, Yih WK, et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics 2010. In press.
  3. Jacobsen SJ, Ackerson BK, Sy LS, et al. Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting. Vaccine 2009; 27:4656-61.
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