Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine

被引：106

作者：

Armstrong, P. K. ^{[1
]}

Dowse, G. K. ^{[1
]}

Effler, P. V. ^{[2
]}

Carcione, D. ^{[1
]}

Blyth, C. C. ^{[3
]}

Richmond, P. C. ^{[3
]}

Geelhoed, G. C. ^{[4
]}

Mascaro, F. ^{[5
]}

Scully, M. ^{[1
]}

Weeramanthri, T. S. ^{[6
]}

机构：

[1] Dept Hlth Western Australia, Communicable Dis Control Directorate, Shenton Pk, WA, Australia

[2] Dept Hlth Western Australia, Prevent & Control Program, Communicable Dis Control Directorate, Shenton Pk, WA, Australia

[3] Univ WA, Sch Paediat & Child Hlth, Princess Margaret Hosp Children, Perth, WA, Australia

[4] Princess Margaret Hosp Children, Dept Emergency Med, Perth, WA, Australia

[5] Princess Margaret Hosp Children, Dept Infect Control, Perth, WA, Australia

[6] Dept Hlth Western Australia, Publ Hlth Div, Perth, WA, Australia

来源：

BMJ OPEN | 2011年 / 1卷 / 01期

关键词：

ADVERSE EVENTS; SAFETY; IMMUNIZATION; IMMUNOGENICITY; INFANTS;

D O I：

10.1136/bmjopen-2010-000016

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: The 2010 influenza vaccination program for children aged 6 months to 4 years in Western Australia (WA) was suspended following reports of severe febrile reactions, including febrile convulsions, following vaccination with trivalent inactivated influenza vaccine (TIV). Methods: To investigate the association between severe febrile reactions and TIV, three studies were conducted: (i) rates of febrile convulsions within 72 h of receiving TIV in 2010 were estimated by vaccine formulation and batch; (ii) numbers of children presenting to hospital emergency departments with febrile convulsions from 2008 to 2010 were compared; and (iii) a retrospective cohort study of 360 children was conducted to compare the reactogenicity of available TIV formulations. Findings: In 2010, an estimated maximum of 18 816 doses of TIV were administered and 63 febrile convulsions were recorded, giving an estimated rate of 3.3 (95% CI 2.6 to 4.2) per 1000 doses of TIV administered. The odds of a TIV-associated febrile convulsion was highly elevated in 2010 (p < 0.001) and was associated with the vaccine formulations of one manufacturer-Fluvax and Fluvax Junior (CSL Biotherapies). The risk of both febrile convulsions (p<0.0001) and other febrile reactions (p<0.0001) was significantly greater for Fluvax formulations compared to the major alternate brand. The risk of febrile events was not associated with prior receipt of TIV or monovalent 2009 H1N1 pandemic vaccine. The biological cause of the febrile reactions is currently unknown. Interpretation: One brand of influenza vaccine was responsible for the increase in febrile reactions, including febrile convulsions. Until the biological reason for this is determined and remediation undertaken, childhood influenza vaccination programs should not include Fluvax-type formulations and enhanced surveillance for febrile reactions in children receiving TIV should be undertaken.

引用

页数：10

共 21 条

[1]

Anonymous, 2010, Morbidity and Mortality Weekly Report, V59, P989

[2]

Australia Government Department of Health and Ageing Immunise Australia Program, 2010, ATAGI STAT CLIN ADV

[3]

Australia Government Department of Health and Ageing Immunise Australia Program, INFL VACC IND AG 6 M

[4]

Australia Government Department of Health and Ageing Immunise Australia Program, CHIEF MED OFF ADV 7

[5]

Australian Government Department of Health and Ageing, 2008, AUSTR IMM HDB

[6]

Australian Government Department of Health and Ageing Therapeutic Goods Administration., 2010, OV VACC REG SAF MON

[7] A Phase III Evaluation of Immunogenicity and Safety of Two Trivalent Inactivated Seasonal Influenza Vaccines in US Children [J].

Baxter, Roger ;

Jeanfreau, Robert ;

Block, Stanley L. ;

Blatter, Mark ;

Pichichero, Michael ;

Jain, Varsha K. ;

Dewe, Walthere ;

Innis, Bruce L. .

PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2010, 29 (10) :924-930

[8] Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation [J].

Bonhoeffer, J ;

Menkes, J ;

Gold, MS ;

de Souza-Brito, G ;

Fisher, MC ;

Halsey, N ;

Vermeer, P .

VACCINE, 2004, 22 (5-6) :557-562

[9] Lessons from the first year of the WAIVE study investigating the protective effect of influenza vaccine against laboratory-confirmed influenza in hospitalised children aged 6-59 months [J].

Dixon, Gabriela A. ;

Moore, Hannah C. ;

Kelly, Heath ;

Jacoby, Peter ;

Carcione, Dale ;

Williams, Simon ;

Smith, David ;

Keil, Anthony D. ;

Van Buynder, Paul ;

Richmond, Peter C. .

INFLUENZA AND OTHER RESPIRATORY VIRUSES, 2010, 4 (04) :231-234

[10]

Nuorti J. Pekka, 2010, Morbidity and Mortality Weekly Report, V59, P1

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