Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting

Jacobsen, Steven J.; Ackerson, Bradley; Sy, Lina S.; Tran, Trung; Jones, T. Stephen; Yao, Janis F.; Xie, Fagen; Cheetham, T. Craig; Saddier, Patricia

doi:10.1016/j.vaccine.2009.05.056

Cited by 123 publications

(68 citation statements)

References 12 publications

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“…This study further confirmed (by using previously unanalyzed data) that MMRV and MMR + V are both associated with fever and seizure 7 to 10 days after vaccination, and validated our previous findings and those of others that MMRV versus MMR + V is associated with an excess risk of seizures 7 to 10 days after vaccination. 19,20,[34][35][36] This study replicated previously reported safety findings, which provides additional reassurance that assessing the 7 main outcomes with this approach was reasonable.…”

Section: Discussionsupporting

confidence: 83%

“…In 2008, Rapid Cycle Analysis monitoring detected increased risk for seizures in 12-to 23-month-old children after MMRV, 18 although not for other safety outcomes. Follow-up studies verified that MMRV is associated with an approximately twofold increased risk of fever and febrile seizures 7 to 10 days after vaccination compared with separate MMR + V. 19,20 The CDC subsequently recommended that either MMRV or MMR + V could be administered to 1-to 2-year-olds receiving their first doses; however, families without a strong preference for MMRV should receive MMR + V. 21 A subsequent study in 4-to 6-year-olds detected no association between MMRV or MMR + V and an increased risk of fever or febrile seizure. 22 Because it is clear that MMRV compared with MMR + V has a higher risk of febrile seizures, we hypothesized that MMRV may present a higher risk for additional safety outcomes.…”

mentioning

confidence: 91%

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Safety of Measles-Containing Vaccines in 1-Year-Old Children

et al. 2015

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BACKGROUND AND OBJECTIVES: All measles-containing vaccines are associated with several types of adverse events, including seizure, fever, and immune thrombocytopenia purpura (ITP). Because the measles-mumps-rubellavaricella (MMRV) vaccine compared with the separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine increases a toddler's risk for febrile seizures, we investigated whether MMRV is riskier than MMR + V and whether either vaccine elevates the risk for additional safety outcomes.

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Section: Discussionsupporting

confidence: 83%

mentioning

confidence: 91%

Safety of Measles-Containing Vaccines in 1-Year-Old Children

et al. 2015

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“…6,7 It is likely that our study also included some children who did not respond to their first dose of MMR and subsequently had a febrile response after MMRV or MMR + V at 4 to 6 years; however, we were unable to specifically identify those potentially vulnerable individuals. Prelicensure studies have not reported differences in postvaccination fever rates between 4-and 6-year-olds receiving MMRV or MMR + V as a second dose.…”

Section: Discussionmentioning

confidence: 99%

“…In 2008, MMRV RCA safety monitoring detected a possible increased risk for seizures after receipt of MMRV. 4 Subsequent studies confirmed that among toddlers 12 to 23 months old, ages when the risk for febrile seizure peaks, 5 measlescontaining vaccines were associated with elevated risk of fever and febrile seizure and MMRV was associated with an ∼2-fold increased risk of fever and febrile seizures occurring 7 to 10 days after MMRV compared with separately administered MMR + V. 6,7 One additional febrile seizure occurred for every 2300 doses of MMRV administered instead of separate MMR + V in 1-year-old children. 6 This finding led to the CDC' s 2010 recommendation that while either MMRV or MMR + V may be administered to 1-to 2-year-olds receiving their first doses, families without a strong preference for MMRV should receive MMR + V. 8 MMR administered as a second dose to 4-to 6-year-old children has not been reported to have an association with an increased risk for febrile seizures.…”

mentioning

confidence: 94%

Measles-Containing Vaccines and Febrile Seizures in Children Age 4 to 6 Years

et al. 2012

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WHAT'S KNOWN ON THIS SUBJECT: Febrile seizure risk 7 to 10 days after measles-mumps-rubella-varicella (MMRV) is double that of separate measles-mumps-rubella (MMR) and varicella vaccines among 1-year-olds. Whether MMRV or MMR and varicella affect febrile seizure risk among 4-to 6-year-olds has not been reported. WHAT THIS STUDY ADDS:Using Vaccine Safety Datalink data, we examined risk for febrile seizures after measles-containing vaccines. This study provides reassurance that MMRV and separately administered MMR and varicella were not associated with increased risk of febrile seizures among 4-to 6-year-olds. abstract BACKGROUND: In the United States, children receive 2 doses of measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), the first between ages 1 to 2 years and the second between ages 4 to 6 years. Among 1-to 2-year-olds, the risk of febrile seizures 7 to 10 days after MMRV is double that after separate MMR + V. Whether MMRV or MMR + V affects risk for febrile seizure risk among 4-to 6-year-olds has not been reported. CONCLUSIONS: This study provides reassurance that MMRV and MMR + V were not associated with increased risk of febrile seizures among 4-to 6-year-olds. We can rule out with 95% confidence a risk greater than 1 febrile seizure per 15 500 MMRV doses and 1 per 18 000 MMR + V doses.

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“…[1][2][3][4] Because we initially defined the 42-day surveillance period, we also examined seizure risk for days 0 to 42, as well as days 0 to 30, to permit comparison with the results of a recent study on MMRV vaccination and febrile seizures. 15 Using the electronic data, we used Poisson regression to compare seizure risk across the 4 different vaccine exposures during days 7 to 10, as well as 5 other risk windows (days 0 -4, 5-6, 11-12, 13-30, and 31-42). Additional covariates adjusted for 5 age groups (12, 13-14, 15-16, 17-19, and 20 -23 months), 7 VSD sites, respiratory virus seasons (November 1 to April 30 versus May 1 to October 31 16 ), and 9 calendar years (2000 -2008).…”

Section: Assessment Of the Effect Of Mmrv On Seizure Riskmentioning

confidence: 99%

Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures

et al. 2010

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WHAT'S KNOWN ON THIS SUBJECT:We previously alerted the ACIP to preliminary evidence of a twofold increased risk of febrile seizures after MMRV when compared with separate MMR and varicella vaccines after monitoring with the VSD RCA surveillance system. WHAT THIS STUDY ADDS:Using VSD data on twice as many vaccines, we examined the effect of MMRV on risk of seizure and describe here the postvaccination risk interval for increased fever and febrile seizures after vaccination. abstract OBJECTIVE: In February 2008, we alerted the Advisory Committee on Immunization Practices to preliminary evidence of a twofold increased risk of febrile seizures after the combination measles-mumps-rubella-varicella (MMRV) vaccine when compared with separate measles-mumps-rubella (MMR) and varicella vaccines. Now with data on twice as many vaccine recipients, our goal was to reexamine seizure risk after MMRV vaccine. METHODS: Using 2000 -2008Vaccine Safety Datalink data, we assessed seizures and fever visits among children aged 12 to 23 months after MMRV and separate MMR ϩ varicella vaccines. We compared seizure risk after MMRV vaccine to that after MMR ϩ varicella vaccines by using Poisson regression as well as with supplementary regressions that incorporated chart-review results and self-controlled analyses. RESULTS:MMRV vaccine recipients (83 107) were compared with recipients of MMR ϩ varicella vaccines (376 354). Seizure and fever significantly clustered 7 to 10 days after vaccination with all measles-containing vaccines but not after varicella vaccination alone. Seizure risk during days 7 to 10 was higher after MMRV than after MMR ϩ varicella vaccination (relative risk: 1.98 [95% confidence interval: 1.43-2.73]). Supplementary analyses yielded similar results. The excess risk for febrile seizures 7 to 10 days after MMRV compared with separate MMR ϩ varicella vaccination was 4.3 per 10 000 doses (95% confidence interval: 2.6 -5.6). CONCLUSIONS:Among 12-to 23-month-olds who received their first dose of measles-containing vaccine, fever and seizure were elevated 7 to 10 days after vaccination. Vaccination with MMRV results in 1 additional febrile seizure for every 2300 doses given instead of separate MMR ϩ varicella vaccines. Providers who recommend MMRV should communicate to parents that it increases the risk of fever and seizure over that already associated with measles-containing vaccines.

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Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting

Cited by 123 publications

References 12 publications

Safety of Measles-Containing Vaccines in 1-Year-Old Children

Safety of Measles-Containing Vaccines in 1-Year-Old Children

Measles-Containing Vaccines and Febrile Seizures in Children Age 4 to 6 Years

Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures

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