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Safety of the Trivalent Inactivated Influenza Vaccine Among Children
A Population-Based Study
Eric K. France, MD, MSPH;
Jason M. Glanz, MS;
Stanley Xu, PhD;
Robert L. Davis, MD, MPH;
Steven B. Black, MD;
Henry R. Shinefield, MD;
Kenneth M. Zangwill, MD;
S. Michael Marcy, MD;
John P. Mullooly, PhD;
Lisa A. Jackson, MD, MPH;
Robert Chen, MD, MA
Arch Pediatr Adolesc Med. 2004;158:1031-1036.
Background To our knowledge, there are no published population-based studies on the safety of the inactivated trivalent influenza vaccine among children.
Objective To screen a large population of children for evidence of increased medical visits in the 2 weeks after influenza vaccination compared with 2 control periods. Secondary analyses included shorter risk periods and restricted age categories.
Design Self-control screening analysis. Children vaccinated from January 1, 1993, through December 31, 1999, were randomly divided into 2 equal groups. In group 1, risks of outpatient, emergency department, and inpatient visits during the 14 days after vaccination were compared with the risks of visits in 2 control periods. Significant plausible medically attended events identified in group 1 were then analyzed in group 2, using the same 2 control periods. Medically attended events significant in both groups were considered potentially associated with vaccination and were assessed by medical record review.
Setting Five managed care organizations in the United States.
Participants Children younger than 18 years who received an influenza vaccination in one of the managed care settings (N = 251 600).
Main Outcome Measure Among vaccinated children seen for a medically attended event, the odds of the visit occurring in the 2 weeks after vaccination vs during 1 of the 2 control periods.
Results Study participants incurred 1165, 230, and 489 different diagnoses during the 14 days after vaccination according to the outpatient, emergency department, and inpatient data, respectively. Four diagnoses were positively associated with the vaccine in both groups 1 and 2: impetigo, dermatitis, uncomplicated diabetes mellitus, and ureteral disorder not otherwise specified. After medical record review, impetigo (9 cases) in children 6 to 23 months old remained significantly associated with vaccination.
Conclusion This large screening safety study did not reveal any evidence of important medically attended events associated with pediatric influenza vaccination.
Author Affiliations: Clinical Research Unit, Kaiser Permanente Colorado, Denver (Drs France and Xu and Mr Glanz); Scientific Advisor to the Centers for Disease Control Vaccine Safety and Development Activities Branch (Dr Davis) and the Immunization Safety Branch (Dr Chen), Centers for Disease Control and Prevention, Atlanta, Ga; Department of Epidemiology, University of Washington, Seattle (Dr Davis); Kaiser Permanente Vaccine Study Center, Northern California Kaiser Permanente, Oakland (Drs Davis, Black, and Shinefield); UCLA Center for Vaccine Research, Torrance, Calif (Dr Zangwill); Southern California Kaiser Permanente, Panorama City (Dr Marcy); Center for Health Research, Northwest Kaiser Permanente, Portland, Ore (Dr Mullooly); and the Center for Health Studies, Group Health Cooperative, (Dr Jackson).
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