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Risk factors associated with anaphylaxis and other allergic-like events following receipt of 2009 monovalent AS03-adjuvanted pandemic influenza vaccine in Quebec, Canada

Identifieur interne : 001D22 ( PascalFrancis/Curation ); précédent : 001D21; suivant : 001D23

Risk factors associated with anaphylaxis and other allergic-like events following receipt of 2009 monovalent AS03-adjuvanted pandemic influenza vaccine in Quebec, Canada

Auteurs : Isabelle Rouleau [Canada] ; Gaston De Serres [Canada] ; Danuta M. Skowronski [Canada] ; Jean Philippe Drolet [Canada] ; Chantal Lemired [Canada] ; Eveline Toth [Canada] ; Monique Landry [Canada]

Source :

RBID : Pascal:14-0143864

Descripteurs français

English descriptors

Abstract

Introduction: In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors. Methods: A total of 435 ALE (50 anaphylaxis) occurring <24 h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression. Results: Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16,95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26,95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls. Conclusion: Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine.
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C01 01    ENG  @0 Introduction: In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors. Methods: A total of 435 ALE (50 anaphylaxis) occurring <24 h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression. Results: Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16,95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26,95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls. Conclusion: Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine.
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Pascal:14-0143864

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<div type="abstract" xml:lang="en">Introduction: In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors. Methods: A total of 435 ALE (50 anaphylaxis) occurring <24 h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression. Results: Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16,95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26,95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls. Conclusion: Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine.</div>
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</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2014 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>34 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>14-0143864</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Vaccine</s0>
</fA64>
<fA66 i1="01">
<s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>Introduction: In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors. Methods: A total of 435 ALE (50 anaphylaxis) occurring <24 h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression. Results: Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16,95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26,95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls. Conclusion: Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002A05F04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Facteur risque</s0>
<s5>05</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Risk factor</s0>
<s5>05</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Factor riesgo</s0>
<s5>05</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Anaphylaxie</s0>
<s5>06</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Anaphylaxis</s0>
<s5>06</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Anafilaxia</s0>
<s5>06</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Adjuvant immunologique</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Immunological adjuvant</s0>
<s5>07</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Coadyuvante inmunológico</s0>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Vaccin</s0>
<s5>08</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Vaccine</s0>
<s5>08</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Vacuna</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Québec</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Quebec</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Quebec</s0>
<s2>NG</s2>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Toxicité</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Toxicity</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Toxicidad</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Hypersensibilité</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Hypersensitivity</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Hipersensibilidad</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Allergie</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Allergy</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Alergia</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Grippe</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Influenza</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Gripe</s0>
<s5>15</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Canada</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Canada</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Canadá</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Amérique du Nord</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>North America</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>America del norte</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Amérique</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>America</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>America</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Immunopathologie</s0>
<s5>13</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Immunopathology</s0>
<s5>13</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Inmunopatología</s0>
<s5>13</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Virose</s0>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Viral disease</s0>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Virosis</s0>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Infection</s0>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Infection</s0>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Infección</s0>
</fC07>
<fN21>
<s1>181</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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