RT Journal
A1 Glanz JM, Newcomer SR, Hambidge SJ, et al
T1 SAfety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the vaccine safety datalink
JF Archives of Pediatrics & Adolescent Medicine
JO Archives of Pediatrics & Adolescent Medicine
YR 2011
FD August 1
VO 165
IS 8
SP 749
OP 755
DO 10.1001/archpediatrics.2011.112
UL http://dx.doi.org/10.1001/archpediatrics.2011.112
AB Objectives 
                  To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate the risk of medically attended events (MAEs) in a subcohort of children who had multiple annual doses of TIV over their lifetimes.Design 
                  Self-controlled screening study.Setting 
                  Seven US managed care organizations from October 1, 2002, to March 31, 2006.Participants 
                  Children aged 24 to 59 months who received at least 1 TIV dose (66 283 children and 91 692 TIV doses).Exposure 
                  Vaccination with TIV.Main Outcome Measures 
                  Medically attended events in inpatient and emergency department settings in one of the following risk windows: 0 to 2, 1 to 14, or 1 to 42 days after vaccination. All MAEs that met the screening criteria of incidence rate ratios (IRRs) exceeding 1.0 and P ≤ .05 or IRRs exceeding 2.0 and P < .20 underwent medical record review. A secondary analysis examined the risk of MAEs in children who had multiple annual lifetime TIV doses.Results 
                  Nine diagnoses met the screening criteria. After medical record review, gastrointestinal tract symptoms (IRR, 1.18; 95% confidence interval [CI], 1.10-1.25), gastrointestinal tract disorders (7.70; 1.11-53.52), and fever (1.71; 1.64-1.80) remained significantly associated with vaccination. None of the events seemed to be serious, and none had complications. In the secondary analysis, there was an apparent dose response for vaccine and allergic reactions in the 1- to 3-day risk window.Conclusions 
                  There was no evidence of serious MAEs following vaccination with TIV among children aged 24 to 59 months. Further studies are warranted to evaluate the risk of MAEs in children with multiple lifetime TIV doses.