The PREGVAXGRIP Study: a Cohort Study to Assess Foetal and Neonatal Consequences of In Utero Exposure to Vaccination Against A(H1N1)v2009 Influenza
Identifieur interne : 000185 ( PascalFrancis/Checkpoint ); précédent : 000184; suivant : 000186The PREGVAXGRIP Study: a Cohort Study to Assess Foetal and Neonatal Consequences of In Utero Exposure to Vaccination Against A(H1N1)v2009 Influenza
Auteurs : F. Chavant [France] ; I. Ingrand [France] ; A. P. Jonville-Bera [France] ; C. Plazanet [France] ; V. Gras-Champel [France] ; L. Lagarce [France] ; M. Zenut [France] ; A. Disson-Dautriche [France] ; S. Logerot ; M. Auffret [France] ; A. Coubret-Dumas [France] ; M. L. Bruel [France] ; M. Boyer ; M. A. Bos-Thompson ; G. Veyrac ; P. Carlier ; M. N. Beyens ; S. Lates [France] ; C. Damase-Michel ; A. Castot ; C. Kreft-Jaïs ; M. C. Perault-Pochat [France]Source :
- Drug safety [ 0114-5916 ] ; 2013.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : France.
- topic : Santé publique, Homme, Vaccination.
English descriptors
- KwdEn :
Abstract
Background In October 2009, in the context of an A(H1N1)v2009 influenza pandemic, a vaccination campaign was launched in France, in which one of the priority groups was pregnant women, on account of the high risk of developing complications following infection by this virus. Objective The aim of this multicentric, prospective, observational study was to assess safety and pregnancy outcomes in a cohort of pregnant women when receiving the A(H1N1)v2009 influenza pandemic vaccine. Methods This was a prospective study that followed up pregnant women recruited mainly in vaccination centres and maternity departments. Following the expected delivery date, follow-up data were collected concerning the delivery, the infant, and, if appropriate, the reasons why the pregnancy did not reach its term. Results Between 1 November 2009 and 31 March 2010, 2,415 pregnant women were included at the time of vaccination; 97.6 % of women received a vaccine without adjuvant and 2.4 % received an adjuvanted vaccine. Ninety-two (3.9 %) women were vaccinated during the first trimester of pregnancy, 1,090 (46.5 %) during the second trimester, and 1,162 (49.6 %) during the third trimester. One hundred and thirty-three adverse events (5.5 % of women) were reported, of which 12 were unexpected or serious. There were 2,246 (93.0 %) known pregnancy outcomes with 12 spontaneous abortions (0.5 %), 6 still-births (0.3 %), and 4 therapeutic abortions (0.2 %). There were 65 neonates with congenital anomalies, among which 31 were major. But only one congenital malformation (1.4 %) was reported for the 92 women vaccinated in their first trimester. Of the women, 93.3 % were delivered full term and 6.7 % preterm. For 96 (4.2 %) neonates, a disorder was reported in the neonatal period and 130 (5.6 %) were transferred to the neonatology department. Conclusions This study suggests that exposure to the A(H1N1)v2009 pandemic influenza vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes. However, because of the relatively small number of women exposed during the first trimester, other studies are needed to exclude an increased risk of malformation.
Affiliations:
- France
- Auvergne (région administrative), Auvergne-Rhône-Alpes, Bourgogne, Bourgogne-Franche-Comté, Centre-Val de Loire, Hauts-de-France, Limousin, Nord-Pas-de-Calais, Nouvelle-Aquitaine, Pays de la Loire, Picardie, Poitou-Charentes, Rhône-Alpes, Région Centre
- Amiens, Angers, Clermont-Ferrand, Dijon, Grenoble, Lille, Limoges, Lyon, Poitiers, Tours
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Castot</name></author><author><name sortKey="Kreft Jais, C" sort="Kreft Jais, C" uniqKey="Kreft Jais C" first="C." last="Kreft-Jaïs">C. Kreft-Jaïs</name></author><author><name sortKey="Perault Pochat, M C" sort="Perault Pochat, M C" uniqKey="Perault Pochat M" first="M. C." last="Perault-Pochat">M. C. Perault-Pochat</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie clinique, Centre Regional de PharmacoVigilance et de Renseignement sur les Medicaments, CHU de Poitiers, 2, rue de la Milétrie</s1><s2>86021 Poitiers</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Nouvelle-Aquitaine</region><region type="old region" nuts="2">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">13-0247640</idno><date when="2013">2013</date><idno type="stanalyst">PASCAL 13-0247640 INIST</idno><idno type="RBID">Pascal:13-0247640</idno><idno type="wicri:Area/PascalFrancis/Corpus">000252</idno><idno type="wicri:Area/PascalFrancis/Curation">001B75</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000185</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000185</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">The PREGVAXGRIP Study: a Cohort Study to Assess Foetal and Neonatal Consequences of In Utero Exposure to Vaccination Against A(H1N1)v2009 Influenza</title><author><name sortKey="Chavant, F" sort="Chavant, F" uniqKey="Chavant F" first="F." last="Chavant">F. Chavant</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie clinique, Centre Regional de PharmacoVigilance et de Renseignement sur les Medicaments, CHU de Poitiers, 2, rue de la Milétrie</s1><s2>86021 Poitiers</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Nouvelle-Aquitaine</region><region type="old region" nuts="2">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author><author><name sortKey="Ingrand, I" sort="Ingrand, I" uniqKey="Ingrand I" first="I." last="Ingrand">I. Ingrand</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie clinique, Centre Regional de PharmacoVigilance et de Renseignement sur les Medicaments, CHU de Poitiers, 2, rue de la Milétrie</s1><s2>86021 Poitiers</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Nouvelle-Aquitaine</region><region type="old region" nuts="2">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author><author><name sortKey="Jonville Bera, A P" sort="Jonville Bera, A P" uniqKey="Jonville Bera A" first="A. P." last="Jonville-Bera">A. P. Jonville-Bera</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Centre Regional de PharmacoVigilance, CHU de Tours</s1><s2>Tours</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Tours</settlement></placeName></affiliation></author><author><name sortKey="Plazanet, C" sort="Plazanet, C" uniqKey="Plazanet C" first="C." last="Plazanet">C. Plazanet</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie clinique, Centre Regional de PharmacoVigilance et de Renseignement sur les Medicaments, CHU de Poitiers, 2, rue de la Milétrie</s1><s2>86021 Poitiers</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Nouvelle-Aquitaine</region><region type="old region" nuts="2">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author><author><name sortKey="Gras Champel, V" sort="Gras Champel, V" uniqKey="Gras Champel V" first="V." last="Gras-Champel">V. Gras-Champel</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Centre Regional de PharmacoVigilance, CHU d'Amiens</s1><s2>Amiens</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Hauts-de-France</region><region type="old region">Picardie</region><settlement type="city">Amiens</settlement></placeName></affiliation></author><author><name sortKey="Lagarce, L" sort="Lagarce, L" uniqKey="Lagarce L" first="L." last="Lagarce">L. Lagarce</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Centre Regional de PharmacoVigilance, CHU d'Angers</s1><s2>Angers</s2><s3>FRA</s3><sZ>6 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Angers</settlement></placeName></affiliation></author><author><name sortKey="Zenut, M" sort="Zenut, M" uniqKey="Zenut M" first="M." last="Zenut">M. Zenut</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Centre Regional de PharmacoVigilance, CHU de Clermont-Ferrand</s1><s2>Clermont-Ferrand</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Auvergne (région administrative)</region><settlement type="city">Clermont-Ferrand</settlement></placeName></affiliation></author><author><name sortKey="Disson Dautriche, A" sort="Disson Dautriche, A" uniqKey="Disson Dautriche A" first="A." last="Disson-Dautriche">A. Disson-Dautriche</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Centre Regional de PharmacoVigilance, CHU de Dijon</s1><s2>Dijon</s2><s3>FRA</s3><sZ>8 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Bourgogne-Franche-Comté</region><region type="old region">Bourgogne</region><settlement type="city">Dijon</settlement></placeName></affiliation></author><author><name sortKey="Logerot, S" sort="Logerot, S" uniqKey="Logerot S" first="S." last="Logerot">S. Logerot</name></author><author><name sortKey="Auffret, M" sort="Auffret, M" uniqKey="Auffret M" first="M." last="Auffret">M. Auffret</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Centre Regional de PharmacoVigilance, CHU de Lille</s1><s2>Lille</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Coubret Dumas, A" sort="Coubret Dumas, A" uniqKey="Coubret Dumas A" first="A." last="Coubret-Dumas">A. Coubret-Dumas</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Centre Regional de PharmacoVigilance, CHU de Limoges</s1><s2>Limoges</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Limousin</region><settlement type="city">Limoges</settlement></placeName></affiliation></author><author><name sortKey="Bruel, M L" sort="Bruel, M L" uniqKey="Bruel M" first="M. L." last="Bruel">M. L. Bruel</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Centre Regional de PharmacoVigilance, CHU de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>12 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Boyer, M" sort="Boyer, M" uniqKey="Boyer M" first="M." last="Boyer">M. Boyer</name></author><author><name sortKey="Bos Thompson, M A" sort="Bos Thompson, M A" uniqKey="Bos Thompson M" first="M. A." last="Bos-Thompson">M. A. Bos-Thompson</name></author><author><name sortKey="Veyrac, G" sort="Veyrac, G" uniqKey="Veyrac G" first="G." last="Veyrac">G. Veyrac</name></author><author><name sortKey="Carlier, P" sort="Carlier, P" uniqKey="Carlier P" first="P." last="Carlier">P. Carlier</name></author><author><name sortKey="Beyens, M N" sort="Beyens, M N" uniqKey="Beyens M" first="M. N." last="Beyens">M. N. Beyens</name></author><author><name sortKey="Lates, S" sort="Lates, S" uniqKey="Lates S" first="S." last="Lates">S. Lates</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Centre Regional de PharmacoVigilance, CHU de Grenoble</s1><s2>Grenoble</s2><s3>FRA</s3><sZ>18 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Grenoble</settlement></placeName></affiliation></author><author><name sortKey="Damase Michel, C" sort="Damase Michel, C" uniqKey="Damase Michel C" first="C." last="Damase-Michel">C. Damase-Michel</name></author><author><name sortKey="Castot, A" sort="Castot, A" uniqKey="Castot A" first="A." last="Castot">A. Castot</name></author><author><name sortKey="Kreft Jais, C" sort="Kreft Jais, C" uniqKey="Kreft Jais C" first="C." last="Kreft-Jaïs">C. Kreft-Jaïs</name></author><author><name sortKey="Perault Pochat, M C" sort="Perault Pochat, M C" uniqKey="Perault Pochat M" first="M. C." last="Perault-Pochat">M. C. Perault-Pochat</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Service de Pharmacologie clinique, Centre Regional de PharmacoVigilance et de Renseignement sur les Medicaments, CHU de Poitiers, 2, rue de la Milétrie</s1><s2>86021 Poitiers</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>22 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Nouvelle-Aquitaine</region><region type="old region" nuts="2">Poitou-Charentes</region><settlement type="city">Poitiers</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Drug safety</title><title level="j" type="abbreviated">Drug saf.</title><idno type="ISSN">0114-5916</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Drug safety</title><title level="j" type="abbreviated">Drug saf.</title><idno type="ISSN">0114-5916</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cohort study</term><term>Female</term><term>France</term><term>H1N1 influenza</term><term>Human</term><term>Neonatal</term><term>Pregnancy</term><term>Prevention</term><term>Public health</term><term>Risk factor</term><term>Teratogen</term><term>Toxicity</term><term>Vaccination</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Santé publique</term><term>Homme</term><term>Etude cohorte</term><term>Néonatal</term><term>Facteur risque</term><term>Vaccination</term><term>Prévention</term><term>France</term><term>Gestation</term><term>Femelle</term><term>Toxicité</term><term>Tératogène</term><term>Influenzavirus A(H1N1)</term><term>Grippe H1N1</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Santé publique</term><term>Homme</term><term>Vaccination</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background In October 2009, in the context of an A(H1N1)v2009 influenza pandemic, a vaccination campaign was launched in France, in which one of the priority groups was pregnant women, on account of the high risk of developing complications following infection by this virus. Objective The aim of this multicentric, prospective, observational study was to assess safety and pregnancy outcomes in a cohort of pregnant women when receiving the A(H1N1)v2009 influenza pandemic vaccine. Methods This was a prospective study that followed up pregnant women recruited mainly in vaccination centres and maternity departments. Following the expected delivery date, follow-up data were collected concerning the delivery, the infant, and, if appropriate, the reasons why the pregnancy did not reach its term. Results Between 1 November 2009 and 31 March 2010, 2,415 pregnant women were included at the time of vaccination; 97.6 % of women received a vaccine without adjuvant and 2.4 % received an adjuvanted vaccine. Ninety-two (3.9 %) women were vaccinated during the first trimester of pregnancy, 1,090 (46.5 %) during the second trimester, and 1,162 (49.6 %) during the third trimester. One hundred and thirty-three adverse events (5.5 % of women) were reported, of which 12 were unexpected or serious. There were 2,246 (93.0 %) known pregnancy outcomes with 12 spontaneous abortions (0.5 %), 6 still-births (0.3 %), and 4 therapeutic abortions (0.2 %). There were 65 neonates with congenital anomalies, among which 31 were major. But only one congenital malformation (1.4 %) was reported for the 92 women vaccinated in their first trimester. Of the women, 93.3 % were delivered full term and 6.7 % preterm. For 96 (4.2 %) neonates, a disorder was reported in the neonatal period and 130 (5.6 %) were transferred to the neonatology department. Conclusions This study suggests that exposure to the A(H1N1)v2009 pandemic influenza vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes. However, because of the relatively small number of women exposed during the first trimester, other studies are needed to exclude an increased risk of malformation.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0114-5916</s0></fA01><fA03 i2="1"><s0>Drug saf.</s0></fA03><fA05><s2>36</s2></fA05><fA06><s2>6</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>The PREGVAXGRIP Study: a Cohort Study to Assess Foetal and Neonatal Consequences of In Utero Exposure to Vaccination Against A(H1N1)v2009 Influenza</s1></fA08><fA11 i1="01" i2="1"><s1>CHAVANT (F.)</s1></fA11><fA11 i1="02" i2="1"><s1>INGRAND (I.)</s1></fA11><fA11 i1="03" i2="1"><s1>JONVILLE-BERA (A. P.)</s1></fA11><fA11 i1="04" i2="1"><s1>PLAZANET (C.)</s1></fA11><fA11 i1="05" i2="1"><s1>GRAS-CHAMPEL (V.)</s1></fA11><fA11 i1="06" i2="1"><s1>LAGARCE (L.)</s1></fA11><fA11 i1="07" i2="1"><s1>ZENUT (M.)</s1></fA11><fA11 i1="08" i2="1"><s1>DISSON-DAUTRICHE (A.)</s1></fA11><fA11 i1="09" i2="1"><s1>LOGEROT (S.)</s1></fA11><fA11 i1="10" i2="1"><s1>AUFFRET (M.)</s1></fA11><fA11 i1="11" i2="1"><s1>COUBRET-DUMAS (A.)</s1></fA11><fA11 i1="12" i2="1"><s1>BRUEL (M. L.)</s1></fA11><fA11 i1="13" i2="1"><s1>BOYER (M.)</s1></fA11><fA11 i1="14" i2="1"><s1>BOS-THOMPSON (M. A.)</s1></fA11><fA11 i1="15" i2="1"><s1>VEYRAC (G.)</s1></fA11><fA11 i1="16" i2="1"><s1>CARLIER (P.)</s1></fA11><fA11 i1="17" i2="1"><s1>BEYENS (M. N.)</s1></fA11><fA11 i1="18" i2="1"><s1>LATES (S.)</s1></fA11><fA11 i1="19" i2="1"><s1>DAMASE-MICHEL (C.)</s1></fA11><fA11 i1="20" i2="1"><s1>CASTOT (A.)</s1></fA11><fA11 i1="21" i2="1"><s1>KREFT-JAÏS (C.)</s1></fA11><fA11 i1="22" i2="1"><s1>PERAULT-POCHAT (M. C.)</s1></fA11><fA14 i1="01"><s1>Service de Pharmacologie clinique, Centre Regional de PharmacoVigilance et de Renseignement sur les Medicaments, CHU de Poitiers, 2, rue de la Milétrie</s1><s2>86021 Poitiers</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>4 aut.</sZ><sZ>22 aut.</sZ></fA14><fA14 i1="02"><s1>Centre Regional de PharmacoVigilance, CHU de Tours</s1><s2>Tours</s2><s3>FRA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="03"><s1>Centre Regional de PharmacoVigilance, CHU d'Amiens</s1><s2>Amiens</s2><s3>FRA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="04"><s1>Centre Regional de PharmacoVigilance, CHU d'Angers</s1><s2>Angers</s2><s3>FRA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="05"><s1>Centre Regional de PharmacoVigilance, CHU de Clermont-Ferrand</s1><s2>Clermont-Ferrand</s2><s3>FRA</s3><sZ>7 aut.</sZ></fA14><fA14 i1="06"><s1>Centre Regional de PharmacoVigilance, CHU de Dijon</s1><s2>Dijon</s2><s3>FRA</s3><sZ>8 aut.</sZ></fA14><fA14 i1="07"><s1>Centre Regional de PharmacoVigilance, CHU de Grenoble</s1><s2>Grenoble</s2><s3>FRA</s3><sZ>18 aut.</sZ></fA14><fA14 i1="08"><s1>Centre Regional de PharmacoVigilance, CHU de Lille</s1><s2>Lille</s2><s3>FRA</s3><sZ>10 aut.</sZ></fA14><fA14 i1="09"><s1>Centre Regional de PharmacoVigilance, CHU de Limoges</s1><s2>Limoges</s2><s3>FRA</s3><sZ>11 aut.</sZ></fA14><fA14 i1="10"><s1>Centre Regional de PharmacoVigilance, CHU de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>12 aut.</sZ></fA14><fA20><s1>455-465</s1></fA20><fA21><s1>2013</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>21755</s2><s5>354000504190020070</s5></fA43><fA44><s0>0000</s0><s1>© 2013 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>33 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>13-0247640</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Drug safety</s0></fA64><fA66 i1="01"><s0>NZL</s0></fA66><fC01 i1="01" l="ENG"><s0>Background In October 2009, in the context of an A(H1N1)v2009 influenza pandemic, a vaccination campaign was launched in France, in which one of the priority groups was pregnant women, on account of the high risk of developing complications following infection by this virus. Objective The aim of this multicentric, prospective, observational study was to assess safety and pregnancy outcomes in a cohort of pregnant women when receiving the A(H1N1)v2009 influenza pandemic vaccine. Methods This was a prospective study that followed up pregnant women recruited mainly in vaccination centres and maternity departments. Following the expected delivery date, follow-up data were collected concerning the delivery, the infant, and, if appropriate, the reasons why the pregnancy did not reach its term. Results Between 1 November 2009 and 31 March 2010, 2,415 pregnant women were included at the time of vaccination; 97.6 % of women received a vaccine without adjuvant and 2.4 % received an adjuvanted vaccine. Ninety-two (3.9 %) women were vaccinated during the first trimester of pregnancy, 1,090 (46.5 %) during the second trimester, and 1,162 (49.6 %) during the third trimester. One hundred and thirty-three adverse events (5.5 % of women) were reported, of which 12 were unexpected or serious. There were 2,246 (93.0 %) known pregnancy outcomes with 12 spontaneous abortions (0.5 %), 6 still-births (0.3 %), and 4 therapeutic abortions (0.2 %). There were 65 neonates with congenital anomalies, among which 31 were major. But only one congenital malformation (1.4 %) was reported for the 92 women vaccinated in their first trimester. Of the women, 93.3 % were delivered full term and 6.7 % preterm. For 96 (4.2 %) neonates, a disorder was reported in the neonatal period and 130 (5.6 %) were transferred to the neonatology department. Conclusions This study suggests that exposure to the A(H1N1)v2009 pandemic influenza vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes. However, because of the relatively small number of women exposed during the first trimester, other studies are needed to exclude an increased risk of malformation.</s0></fC01><fC02 i1="01" i2="X"><s0>002B05C02C</s0></fC02><fC02 i1="02" i2="X"><s0>002B02U10</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Santé publique</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Public health</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Salud pública</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Homme</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Human</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Hombre</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Etude cohorte</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Cohort study</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Estudio cohorte</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Néonatal</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Neonatal</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Neonatal</s0><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Facteur risque</s0><s5>06</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Risk factor</s0><s5>06</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Factor riesgo</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Vaccination</s0><s5>07</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Vaccination</s0><s5>07</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Vacunación</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Prévention</s0><s5>08</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Prevention</s0><s5>08</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Prevención</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>France</s0><s2>NG</s2><s5>09</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>France</s0><s2>NG</s2><s5>09</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Francia</s0><s2>NG</s2><s5>09</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Gestation</s0><s5>10</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Pregnancy</s0><s5>10</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Gestación</s0><s5>10</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Femelle</s0><s5>11</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Female</s0><s5>11</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Hembra</s0><s5>11</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Toxicité</s0><s5>12</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Toxicity</s0><s5>12</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Toxicidad</s0><s5>12</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Tératogène</s0><s5>13</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Teratogen</s0><s5>13</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Teratogeno</s0><s5>13</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Influenzavirus A(H1N1)</s0><s4>INC</s4><s5>86</s5></fC03><fC03 i1="14" i2="X" l="FRE"><s0>Grippe H1N1</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="14" i2="X" l="ENG"><s0>H1N1 influenza</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="14" i2="X" l="SPA"><s0>Gripe H1N1</s0><s4>CD</s4><s5>96</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Europe</s0><s2>NG</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Europe</s0><s2>NG</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Europa</s0><s2>NG</s2></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Pathologie de l'appareil respiratoire</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Respiratory disease</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Aparato respiratorio patología</s0><s5>37</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Virose</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Viral disease</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Virosis</s0><s5>38</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Infection</s0></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Infection</s0></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Infección</s0></fC07><fN21><s1>238</s1></fN21></pA></standard></inist><affiliations><list><country><li>France</li></country><region><li>Auvergne (région administrative)</li><li>Auvergne-Rhône-Alpes</li><li>Bourgogne</li><li>Bourgogne-Franche-Comté</li><li>Centre-Val de Loire</li><li>Hauts-de-France</li><li>Limousin</li><li>Nord-Pas-de-Calais</li><li>Nouvelle-Aquitaine</li><li>Pays de la Loire</li><li>Picardie</li><li>Poitou-Charentes</li><li>Rhône-Alpes</li><li>Région Centre</li></region><settlement><li>Amiens</li><li>Angers</li><li>Clermont-Ferrand</li><li>Dijon</li><li>Grenoble</li><li>Lille</li><li>Limoges</li><li>Lyon</li><li>Poitiers</li><li>Tours</li></settlement></list><tree><noCountry><name sortKey="Beyens, M N" sort="Beyens, M N" uniqKey="Beyens M" first="M. N." last="Beyens">M. N. Beyens</name><name sortKey="Bos Thompson, M A" sort="Bos Thompson, M A" uniqKey="Bos Thompson M" first="M. A." last="Bos-Thompson">M. A. Bos-Thompson</name><name sortKey="Boyer, M" sort="Boyer, M" uniqKey="Boyer M" first="M." last="Boyer">M. Boyer</name><name sortKey="Carlier, P" sort="Carlier, P" uniqKey="Carlier P" first="P." last="Carlier">P. Carlier</name><name sortKey="Castot, A" sort="Castot, A" uniqKey="Castot A" first="A." last="Castot">A. Castot</name><name sortKey="Damase Michel, C" sort="Damase Michel, C" uniqKey="Damase Michel C" first="C." last="Damase-Michel">C. Damase-Michel</name><name sortKey="Kreft Jais, C" sort="Kreft Jais, C" uniqKey="Kreft Jais C" first="C." last="Kreft-Jaïs">C. Kreft-Jaïs</name><name sortKey="Logerot, S" sort="Logerot, S" uniqKey="Logerot S" first="S." last="Logerot">S. Logerot</name><name sortKey="Veyrac, G" sort="Veyrac, G" uniqKey="Veyrac G" first="G." last="Veyrac">G. Veyrac</name></noCountry><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Chavant, F" sort="Chavant, F" uniqKey="Chavant F" first="F." last="Chavant">F. Chavant</name></region><name sortKey="Auffret, M" sort="Auffret, M" uniqKey="Auffret M" first="M." last="Auffret">M. Auffret</name><name sortKey="Bruel, M L" sort="Bruel, M L" uniqKey="Bruel M" first="M. L." last="Bruel">M. L. Bruel</name><name sortKey="Coubret Dumas, A" sort="Coubret Dumas, A" uniqKey="Coubret Dumas A" first="A." last="Coubret-Dumas">A. Coubret-Dumas</name><name sortKey="Disson Dautriche, A" sort="Disson Dautriche, A" uniqKey="Disson Dautriche A" first="A." last="Disson-Dautriche">A. Disson-Dautriche</name><name sortKey="Gras Champel, V" sort="Gras Champel, V" uniqKey="Gras Champel V" first="V." last="Gras-Champel">V. Gras-Champel</name><name sortKey="Ingrand, I" sort="Ingrand, I" uniqKey="Ingrand I" first="I." last="Ingrand">I. Ingrand</name><name sortKey="Jonville Bera, A P" sort="Jonville Bera, A P" uniqKey="Jonville Bera A" first="A. P." last="Jonville-Bera">A. P. Jonville-Bera</name><name sortKey="Lagarce, L" sort="Lagarce, L" uniqKey="Lagarce L" first="L." last="Lagarce">L. Lagarce</name><name sortKey="Lates, S" sort="Lates, S" uniqKey="Lates S" first="S." last="Lates">S. Lates</name><name sortKey="Perault Pochat, M C" sort="Perault Pochat, M C" uniqKey="Perault Pochat M" first="M. C." last="Perault-Pochat">M. C. Perault-Pochat</name><name sortKey="Plazanet, C" sort="Plazanet, C" uniqKey="Plazanet C" first="C." last="Plazanet">C. Plazanet</name><name sortKey="Zenut, M" sort="Zenut, M" uniqKey="Zenut M" first="M." last="Zenut">M. Zenut</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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