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Risk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children: an analysis of the Vaccine Safety Datalink (VSD) Project

BLACK, STEVEN MD; SHINEFIELD, HENRY MD; RAY, PAULA MPH; LEWIS, EDWIN MPH; CHEN, ROBERT MD; GLASSER, JOHN PHD; HADLER, STEVEN MD; HARDY, JANET MPH, MS; RHODES, PHIL PHD; SWINT, EMMET MA; DAVIS, ROBERT MD; THOMPSON, ROBERT MD; MULLOOLY, JOHN PHD; MARCY, MICHAEL MD; VADHEIM, CONNIE PHD; WARD, JOEL MD; RASTOGI, SURESH PHD; WISE, ROBERT MDTHE VACCINE SAFETY DATALINK GROUP

The Pediatric Infectious Disease Journal: May 1997 - Volume 16 - Issue 5 - p 500-503
Original Studies

Objective. To assess the level of increased risk, if any, of hospitalizations for aseptic meningitis after Jeryl-Lynn mumps strain measles-mumps-rubella (MMR) vaccine in the Vaccine Safety Datalink population.

Study design. A possible increased risk of aseptic meningitis 8 to 14 days after receipt of MMR was observed in a preliminary screening analysis of automated data from the Vaccine Safety Datalink (VSD) project Year 2 analysis. To further evaluate this association a retrospective 10-year matched case-control study was undertaken in the four health maintenance organizations (HMOs) in the VSD project. Cases ascertained from a broad scan of the automated data were validated against a standard case definition. Two controls matched on age, sex, HMO and HMO membership were assigned per case.

Results. The VSD project involves the cooperative collection of automated vaccination and medical outcome data from four large HMOs that currently have 500 000 children younger than 7 years of age under surveillance. Review of automated screening results from the first 2 years of data revealed a possible increased risk of aseptic meningitis 0 to 14 days after MMR with a relative risk of 3.61 (95% confidence interval, 1.0 to 13.1) although the total number of cases was small. Although the automated data had suggested a possible association of aseptic meningitis with MMR containing the Jeryl-Lynn strain of mumps, review of validated hospitalized cases during the observation period did not reveal evidence of an increased risk of aseptic meningitis after MMR containing the Jeryl-Lynn strain of mumps (odds ratio <1.0 for all analyses).

Conclusion. Although it is recognized that hospitalized cases represent a minority of the total cases of aseptic meningitis, it is reassuring that in this evaluation no increased risk of aseptic meningitis after MMR vaccine was found.

From the Kaiser Permanente Vaccine Study Center, Oakland, CA (SB, HS, PaR, EL); the National Immunization Program, Centers for Disease Control, Atlanta, GA (RC, JG, SH, JH, PhR, ES); Group Health Cooperative, Seattle, WA (RD, RT); 4 Kaiser Permanente Northwest Region, Portland, OR (JM); Southern California Kaiser Permanente, Panorama City, CA (MM); UCLA Vaccine Study Center, Torrance, CA (CV, JW); and the Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD (SR, RW).

Accepted for publication Jan. 28, 1997.

Address for reprints: Steven Black, M.D., Kaiser Permanente Medical Center, 280 West MacArthur Blvd., Oakland, CA 94611. Fax 510-596-6575 [fax]; E-mail steve.black@ncal.kaiperm.org.

© Williams & Wilkins 1997. All Rights Reserved.