Published online May 1, 2006
PEDIATRICS Vol. 117 No. 5 May 2006, pp. e821-e826 (doi:10.1542/peds.2005-2234)
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Influenza

The Safety of Trivalent Influenza Vaccine Among Healthy Children 6 to 24 Months of Age

Michael J. Goodman, PhDa, James D. Nordin, MD, MPHa, Peter Harper, MD, MPHb, Teri DeFor, MSa and XingZhou Zhou, MSa

a HealthPartners Research Foundation, Minneapolis, Minnesota
b Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, Minnesota

OBJECTIVE. The objective of this study was to assess the safety of routine trivalent influenza vaccine (TIV) administration among healthy children 6 through 23 months of age, after the Advisory Committee on Immunization Practices recommendation.

METHODS. The study was a retrospective case-control study of children receiving TIV in the first 2 seasons after the Advisory Committee on Immunization Practices recommendation. We assessed outcomes in the 42 days after vaccination in a population of 13383 children. Each case subject was matched, according to age and gender, with 3 control subjects. Hazard ratios were calculated with conditional logistic regression analysis.

RESULTS. We found no statistically significantly elevated hazard ratios for the first TIV dose. An elevated risk of pharyngitis was found for children receiving a second TIV dose. No elevated risk of seizure was found.

CONCLUSION. These results, for a population of healthy children, showed no medically significant adverse events related to TIV among children 6 to 23 months of age.

Key Words: safety • trivalent influenza vaccine • adverse events

Abbreviations: ACIP—Advisory Committee on Immunization Practices • HPMG—HealthPartners Medical Group • TIV—trivalent influenza vaccine • VSD—Vaccine Safety Datalink • VAERS—Vaccine Adverse Event Reporting System • CI—confidence interval

Accepted Nov 4, 2005.




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