TY  - JOUR
T1  - Safety of the trivalent inactivated influenza vaccine among children: A population-based study
AU  - France EK, Glanz JM, Xu S, et al
Y1  - 2004/11/01
N1  - 10.1001/archpedi.158.11.1031
JO  - Archives of Pediatrics & Adolescent Medicine
SP  - 1031
EP  - 1036
VL  - 158
IS  - 11
N2  - 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.
SN  - 1072-4710
M3  - doi: 10.1001/archpedi.158.11.1031
UR  - http://dx.doi.org/10.1001/archpedi.158.11.1031
ER  -