Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark
Identifieur interne : 000776 ( Main/Exploration ); précédent : 000775; suivant : 000777Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark
Auteurs : Björn Pasternak [Danemark, Suède] ; Henrik Svanström [Danemark] ; Ditte M Lgaard-Nielsen [Danemark] ; Tyra G. Krause [Danemark] ; Hanne-Dorthe Emborg [Danemark] ; Mads Melbye [Danemark] ; Anders Hviid [Danemark]Source :
- BMJ : British Medical Journal [ 1756-1833 ] ; 2012.
Abstract
Objective To investigate whether an adjuvanted pandemic A/H1N1 2009 influenza vaccine in pregnancy was associated with an increased risk of fetal death. Design Nationwide register based cohort study. Setting Denmark. Participants All clinically recognised singleton pregnancies that ended between November 2009 and September 2010. Individual level data on exposure to an inactivated AS03 pandemic A/H1N1 2009 influenza vaccine (Pandemrix) and potential confounders were linked to the study cohort using a unique person identifier. Main outcome measures The primary outcome measure was risk of fetal death (spontaneous abortion and stillbirth combined) in H1N1 vaccinated compared with unvaccinated pregnancies, adjusting for propensity scores. Secondary outcome measures were spontaneous abortion (between seven and 22 weeks’ gestation) and stillbirth (after 22 completed weeks’ gestation). Results The cohort comprised 54 585 pregnancies; 7062 (12.9%) women were vaccinated against pandemic A/H1N1 2009 influenza during pregnancy. Overall, 1818 fetal deaths occurred (1678 spontaneous abortions and 140 stillbirths). Exposure to the H1N1 vaccine was not associated with an increased risk of fetal death (adjusted hazard ratio 0.79, 95% confidence interval 0.53 to 1.16), or the secondary outcomes of spontaneous abortion (1.11, 0.71 to 1.73) and stillbirth (0.44, 0.20 to 0.94). Estimates for fetal death were similar in pregnant women with (0.82, 0.44 to 1.53) and without comorbidities (0.77, 0.47 to 1.25). Conclusion This large cohort study found no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy.
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DOI: 10.1136/bmj.e2794
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Krause</name></author><author><name sortKey="Emborg, Hanne Dorthe" sort="Emborg, Hanne Dorthe" uniqKey="Emborg H" first="Hanne-Dorthe" last="Emborg">Hanne-Dorthe Emborg</name></author><author><name sortKey="Melbye, Mads" sort="Melbye, Mads" uniqKey="Melbye M" first="Mads" last="Melbye">Mads Melbye</name></author><author><name sortKey="Hviid, Anders" sort="Hviid, Anders" uniqKey="Hviid A" first="Anders" last="Hviid">Anders Hviid</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:6FAA0DFFC30555CBF92612D68D1EC3BCF0F06FB0</idno><date when="2012" year="2012">2012</date><idno type="doi">10.1136/bmj.e2794</idno><idno type="url">https://api.istex.fr/document/6FAA0DFFC30555CBF92612D68D1EC3BCF0F06FB0/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000D89</idno><idno type="wicri:Area/Istex/Curation">000D80</idno><idno type="wicri:Area/Istex/Checkpoint">000389</idno><idno type="wicri:Area/Main/Merge">000777</idno><idno type="wicri:Area/Main/Curation">000776</idno><idno type="wicri:Area/Main/Exploration">000776</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark</title><author><name sortKey="Pasternak, Bjorn" sort="Pasternak, Bjorn" uniqKey="Pasternak B" first="Björn" last="Pasternak">Björn Pasternak</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Clinical Sciences, Infectious Diseases Unit, Lund University, Malmö</wicri:regionArea><wicri:noRegion>Malmö</wicri:noRegion></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Danemark</country></affiliation></author><author><name sortKey="Svanstrom, Henrik" sort="Svanstrom, Henrik" uniqKey="Svanstrom H" first="Henrik" last="Svanström">Henrik Svanström</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="M Lgaard Nielsen, Ditte" sort="M Lgaard Nielsen, Ditte" uniqKey="M Lgaard Nielsen D" first="Ditte" last="M Lgaard-Nielsen">Ditte M Lgaard-Nielsen</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Krause, Tyra G" sort="Krause, Tyra G" uniqKey="Krause T" first="Tyra G" last="Krause">Tyra G. Krause</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Infectious Disease Epidemiology, Statens Serum Institut, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Emborg, Hanne Dorthe" sort="Emborg, Hanne Dorthe" uniqKey="Emborg H" first="Hanne-Dorthe" last="Emborg">Hanne-Dorthe Emborg</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Infectious Disease Epidemiology, Statens Serum Institut, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Melbye, Mads" sort="Melbye, Mads" uniqKey="Melbye M" first="Mads" last="Melbye">Mads Melbye</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Hviid, Anders" sort="Hviid, Anders" uniqKey="Hviid A" first="Anders" last="Hviid">Anders Hviid</name><affiliation wicri:level="3"><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300, Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">BMJ : British Medical Journal</title><title level="j" type="abbrev">BMJ</title><idno type="eISSN">1756-1833</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2012">2012</date><biblScope unit="volume">344</biblScope></imprint></series><idno type="istex">6FAA0DFFC30555CBF92612D68D1EC3BCF0F06FB0</idno><idno type="DOI">10.1136/bmj.e2794</idno><idno type="href">bmj-344-bmj-e2794.pdf</idno><idno type="ArticleID">pasb003549</idno><idno type="local">bmj;344/may02_1/e2794</idno></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective To investigate whether an adjuvanted pandemic A/H1N1 2009 influenza vaccine in pregnancy was associated with an increased risk of fetal death. Design Nationwide register based cohort study. Setting Denmark. Participants All clinically recognised singleton pregnancies that ended between November 2009 and September 2010. Individual level data on exposure to an inactivated AS03 pandemic A/H1N1 2009 influenza vaccine (Pandemrix) and potential confounders were linked to the study cohort using a unique person identifier. Main outcome measures The primary outcome measure was risk of fetal death (spontaneous abortion and stillbirth combined) in H1N1 vaccinated compared with unvaccinated pregnancies, adjusting for propensity scores. Secondary outcome measures were spontaneous abortion (between seven and 22 weeks’ gestation) and stillbirth (after 22 completed weeks’ gestation). Results The cohort comprised 54 585 pregnancies; 7062 (12.9%) women were vaccinated against pandemic A/H1N1 2009 influenza during pregnancy. Overall, 1818 fetal deaths occurred (1678 spontaneous abortions and 140 stillbirths). Exposure to the H1N1 vaccine was not associated with an increased risk of fetal death (adjusted hazard ratio 0.79, 95% confidence interval 0.53 to 1.16), or the secondary outcomes of spontaneous abortion (1.11, 0.71 to 1.73) and stillbirth (0.44, 0.20 to 0.94). Estimates for fetal death were similar in pregnant women with (0.82, 0.44 to 1.53) and without comorbidities (0.77, 0.47 to 1.25). Conclusion This large cohort study found no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy.</div></front></TEI><affiliations><list><country><li>Danemark</li><li>Suède</li></country><region><li>Hovedstaden</li></region><settlement><li>Copenhague</li></settlement></list><tree><country name="Danemark"><region name="Hovedstaden"><name sortKey="Pasternak, Bjorn" sort="Pasternak, Bjorn" uniqKey="Pasternak B" first="Björn" last="Pasternak">Björn Pasternak</name></region><name sortKey="Emborg, Hanne Dorthe" sort="Emborg, Hanne Dorthe" uniqKey="Emborg H" first="Hanne-Dorthe" last="Emborg">Hanne-Dorthe Emborg</name><name sortKey="Hviid, Anders" sort="Hviid, Anders" uniqKey="Hviid A" first="Anders" last="Hviid">Anders Hviid</name><name sortKey="Krause, Tyra G" sort="Krause, Tyra G" uniqKey="Krause T" first="Tyra G" last="Krause">Tyra G. Krause</name><name sortKey="M Lgaard Nielsen, Ditte" sort="M Lgaard Nielsen, Ditte" uniqKey="M Lgaard Nielsen D" first="Ditte" last="M Lgaard-Nielsen">Ditte M Lgaard-Nielsen</name><name sortKey="Melbye, Mads" sort="Melbye, Mads" uniqKey="Melbye M" first="Mads" last="Melbye">Mads Melbye</name><name sortKey="Pasternak, Bjorn" sort="Pasternak, Bjorn" uniqKey="Pasternak B" first="Björn" last="Pasternak">Björn Pasternak</name><name sortKey="Svanstrom, Henrik" sort="Svanstrom, Henrik" uniqKey="Svanstrom H" first="Henrik" last="Svanström">Henrik Svanström</name></country><country name="Suède"><noRegion><name sortKey="Pasternak, Bjorn" sort="Pasternak, Bjorn" uniqKey="Pasternak B" first="Björn" last="Pasternak">Björn Pasternak</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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