Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old

Simon J. Hambidge, Jason M. Glanz, Eric K. France, David McClure, Stanley Xu, Kristi Yamasaki, Lisa Jackson, John P. Mullooly, Kenneth M. Zangwill, S. Michael Marcy, Steven B. Black, Edwin M. Lewis, Henry R. Shinefield, Edward Belongia, James Nordin, Robert T. Chen, David K. Shay, Robert Davis, Frank DeStefano

Research output: Contribution to journalArticle

106 Citations (Scopus)

Abstract

Context: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. Objective: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. Design, Setting, and Participants: Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45 356 children with 69 359 vaccinations). Main Outcome Measure: Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. Results: Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95% confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95% CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95% CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95% CI, 0.92-12.11 for control period 2). Conclusions: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.

Original languageEnglish (US)
Pages (from-to)1990-1997
Number of pages8
JournalJournal of the American Medical Association
Volume296
Issue number16
DOIs
StatePublished - Oct 25 2006

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Inactivated Vaccines
Influenza Vaccines
Safety
Vaccination
Odds Ratio
Duodenitis
Confidence Intervals
Vaccines
International Classification of Diseases
Gastritis
Hospital Administration
Bronchiolitis
Otitis Media
Managed Care Programs
Respiratory Tract Infections
Human Influenza
Population
Hospital Emergency Service
Asthma
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Hambidge, S. J., Glanz, J. M., France, E. K., McClure, D., Xu, S., Yamasaki, K., ... DeStefano, F. (2006). Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. Journal of the American Medical Association, 296(16), 1990-1997. https://doi.org/10.1001/jama.296.16.1990

Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. / Hambidge, Simon J.; Glanz, Jason M.; France, Eric K.; McClure, David; Xu, Stanley; Yamasaki, Kristi; Jackson, Lisa; Mullooly, John P.; Zangwill, Kenneth M.; Marcy, S. Michael; Black, Steven B.; Lewis, Edwin M.; Shinefield, Henry R.; Belongia, Edward; Nordin, James; Chen, Robert T.; Shay, David K.; Davis, Robert; DeStefano, Frank.

In: Journal of the American Medical Association, Vol. 296, No. 16, 25.10.2006, p. 1990-1997.

Research output: Contribution to journalArticle

Hambidge, SJ, Glanz, JM, France, EK, McClure, D, Xu, S, Yamasaki, K, Jackson, L, Mullooly, JP, Zangwill, KM, Marcy, SM, Black, SB, Lewis, EM, Shinefield, HR, Belongia, E, Nordin, J, Chen, RT, Shay, DK, Davis, R & DeStefano, F 2006, 'Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old', Journal of the American Medical Association, vol. 296, no. 16, pp. 1990-1997. https://doi.org/10.1001/jama.296.16.1990
Hambidge, Simon J. ; Glanz, Jason M. ; France, Eric K. ; McClure, David ; Xu, Stanley ; Yamasaki, Kristi ; Jackson, Lisa ; Mullooly, John P. ; Zangwill, Kenneth M. ; Marcy, S. Michael ; Black, Steven B. ; Lewis, Edwin M. ; Shinefield, Henry R. ; Belongia, Edward ; Nordin, James ; Chen, Robert T. ; Shay, David K. ; Davis, Robert ; DeStefano, Frank. / Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. In: Journal of the American Medical Association. 2006 ; Vol. 296, No. 16. pp. 1990-1997.
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abstract = "Context: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. Objective: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. Design, Setting, and Participants: Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45 356 children with 69 359 vaccinations). Main Outcome Measure: Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. Results: Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95{\%} confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95{\%} CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95{\%} CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95{\%} CI, 0.92-12.11 for control period 2). Conclusions: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.",
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AU - Hambidge, Simon J.

AU - Glanz, Jason M.

AU - France, Eric K.

AU - McClure, David

AU - Xu, Stanley

AU - Yamasaki, Kristi

AU - Jackson, Lisa

AU - Mullooly, John P.

AU - Zangwill, Kenneth M.

AU - Marcy, S. Michael

AU - Black, Steven B.

AU - Lewis, Edwin M.

AU - Shinefield, Henry R.

AU - Belongia, Edward

AU - Nordin, James

AU - Chen, Robert T.

AU - Shay, David K.

AU - Davis, Robert

AU - DeStefano, Frank

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N2 - Context: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. Objective: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. Design, Setting, and Participants: Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45 356 children with 69 359 vaccinations). Main Outcome Measure: Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. Results: Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95% confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95% CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95% CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95% CI, 0.92-12.11 for control period 2). Conclusions: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.

AB - Context: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. Objective: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. Design, Setting, and Participants: Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45 356 children with 69 359 vaccinations). Main Outcome Measure: Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. Results: Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95% confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95% CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95% CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95% CI, 0.92-12.11 for control period 2). Conclusions: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.

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