Pharmacovigilance monitoring of a cohort of pregnant women vaccinated against influenza A(H1N1) variant virus in the Nord-Pas de Calais region of northern France.
Identifieur interne : 000271 ( Main/Exploration ); précédent : 000270; suivant : 000272Pharmacovigilance monitoring of a cohort of pregnant women vaccinated against influenza A(H1N1) variant virus in the Nord-Pas de Calais region of northern France.
Auteurs : Marine Auffret [France] ; Johana Béné ; Sophie Gautier ; Sophie Moreau-Crépeaux ; Jacques CaronSource :
- European journal of obstetrics, gynecology, and reproductive biology [ 1872-7654 ] ; 2013.
Descripteurs français
- KwdFr :
- Complications infectieuses de la grossesse (prévention et contrôle), Femelle (MeSH), France (MeSH), Grippe humaine (prévention et contrôle), Grossesse (MeSH), Humains (MeSH), Issue de la grossesse (MeSH), Mâle (MeSH), Nouveau-né (MeSH), Pharmacovigilance (MeSH), Sous-type H1N1 du virus de la grippe A (MeSH), Vaccins antigrippaux (effets indésirables), Études prospectives (MeSH).
- MESH :
- effets indésirables : Vaccins antigrippaux.
- prévention et contrôle : Complications infectieuses de la grossesse, Grippe humaine.
- Femelle, France, Grossesse, Humains, Issue de la grossesse, Mâle, Nouveau-né, Pharmacovigilance, Sous-type H1N1 du virus de la grippe A, Études prospectives.
- Wicri :
- geographic : France.
English descriptors
- KwdEn :
- Female (MeSH), France (MeSH), Humans (MeSH), Infant, Newborn (MeSH), Influenza A Virus, H1N1 Subtype (MeSH), Influenza Vaccines (adverse effects), Influenza, Human (prevention & control), Male (MeSH), Pharmacovigilance (MeSH), Pregnancy (MeSH), Pregnancy Complications, Infectious (prevention & control), Pregnancy Outcome (MeSH), Prospective Studies (MeSH).
- MESH :
- chemical , adverse effects : Influenza Vaccines.
- geographic : France.
- prevention & control : Influenza, Human, Pregnancy Complications, Infectious.
- Female, Humans, Infant, Newborn, Influenza A Virus, H1N1 Subtype, Male, Pharmacovigilance, Pregnancy, Pregnancy Outcome, Prospective Studies.
Abstract
OBJECTIVE
During the 2009-2010 influenza A variant virus (A(H1N1)v) pandemic in France, a national pharmacovigilance program was set up to monitor vaccinated, pregnant women, especially the reactogenicity of the vaccine and its impact on the outcome of pregnancy and on the newborn. Here, we present the results for the cohort of pregnant women constituted in the Nord-Pas de Calais region of northern France.
STUDY DESIGN
Vaccinated pregnant women were included in the study by the region's vaccination centers between November 2009 and April 2010.
RESULTS
Eight hundred and six pregnant women were included and 781 were followed up until delivery. The risk of adverse events after vaccination and the maternal, fetal and neonatal medical conditions in our cohort did not appear different from the risk observed in the general population.
CONCLUSIONS
Our results suggest that A(H1N1)v vaccination of pregnant women did not have an adverse impact on the pregnancies' course and outcome.
DOI: 10.1016/j.ejogrb.2013.05.025
PubMed: 23810001
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Electronic address: marine.auffret@wanadoo.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Regional Center of Pharmacovigilance, CRPV, Service de Pharmacologie, CHRU de Lille - 1, place de Verdun, 59045 Lille Cedex</wicri:regionArea><placeName><region type="region" nuts="2">Hauts-de-France</region><region type="old region" nuts="2">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Bene, Johana" sort="Bene, Johana" uniqKey="Bene J" first="Johana" last="Béné">Johana Béné</name></author><author><name sortKey="Gautier, Sophie" sort="Gautier, Sophie" uniqKey="Gautier S" first="Sophie" last="Gautier">Sophie Gautier</name></author><author><name sortKey="Moreau Crepeaux, Sophie" sort="Moreau Crepeaux, Sophie" uniqKey="Moreau Crepeaux S" first="Sophie" last="Moreau-Crépeaux">Sophie Moreau-Crépeaux</name></author><author><name sortKey="Caron, Jacques" sort="Caron, Jacques" uniqKey="Caron J" first="Jacques" last="Caron">Jacques Caron</name></author></analytic><series><title level="j">European journal of obstetrics, gynecology, and reproductive biology</title><idno type="eISSN">1872-7654</idno><imprint><date when="2013" type="published">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Female (MeSH)</term><term>France (MeSH)</term><term>Humans (MeSH)</term><term>Infant, Newborn (MeSH)</term><term>Influenza A Virus, H1N1 Subtype (MeSH)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza, Human (prevention & control)</term><term>Male (MeSH)</term><term>Pharmacovigilance (MeSH)</term><term>Pregnancy (MeSH)</term><term>Pregnancy Complications, Infectious (prevention & control)</term><term>Pregnancy Outcome (MeSH)</term><term>Prospective Studies (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Complications infectieuses de la grossesse (prévention et contrôle)</term><term>Femelle (MeSH)</term><term>France (MeSH)</term><term>Grippe humaine (prévention et contrôle)</term><term>Grossesse (MeSH)</term><term>Humains (MeSH)</term><term>Issue de la grossesse (MeSH)</term><term>Mâle (MeSH)</term><term>Nouveau-né (MeSH)</term><term>Pharmacovigilance (MeSH)</term><term>Sous-type H1N1 du virus de la grippe A (MeSH)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Études prospectives (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term><term>Pregnancy Complications, Infectious</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Complications infectieuses de la grossesse</term><term>Grippe humaine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Female</term><term>Humans</term><term>Infant, Newborn</term><term>Influenza A Virus, H1N1 Subtype</term><term>Male</term><term>Pharmacovigilance</term><term>Pregnancy</term><term>Pregnancy Outcome</term><term>Prospective Studies</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Femelle</term><term>France</term><term>Grossesse</term><term>Humains</term><term>Issue de la grossesse</term><term>Mâle</term><term>Nouveau-né</term><term>Pharmacovigilance</term><term>Sous-type H1N1 du virus de la grippe A</term><term>Études prospectives</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>During the 2009-2010 influenza A variant virus (A(H1N1)v) pandemic in France, a national pharmacovigilance program was set up to monitor vaccinated, pregnant women, especially the reactogenicity of the vaccine and its impact on the outcome of pregnancy and on the newborn. Here, we present the results for the cohort of pregnant women constituted in the Nord-Pas de Calais region of northern France.</p></div><div type="abstract" xml:lang="en"><p><b>STUDY DESIGN</b></p><p>Vaccinated pregnant women were included in the study by the region's vaccination centers between November 2009 and April 2010.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Eight hundred and six pregnant women were included and 781 were followed up until delivery. The risk of adverse events after vaccination and the maternal, fetal and neonatal medical conditions in our cohort did not appear different from the risk observed in the general population.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Our results suggest that A(H1N1)v vaccination of pregnant women did not have an adverse impact on the pregnancies' course and outcome.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23810001</PMID><DateCompleted><Year>2014</Year><Month>06</Month><Day>02</Day></DateCompleted><DateRevised><Year>2013</Year><Month>08</Month><Day>26</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1872-7654</ISSN><JournalIssue CitedMedium="Internet"><Volume>170</Volume><Issue>1</Issue><PubDate><Year>2013</Year><Month>Sep</Month></PubDate></JournalIssue><Title>European journal of obstetrics, gynecology, and reproductive biology</Title><ISOAbbreviation>Eur. J. Obstet. Gynecol. Reprod. Biol.</ISOAbbreviation></Journal><ArticleTitle>Pharmacovigilance monitoring of a cohort of pregnant women vaccinated against influenza A(H1N1) variant virus in the Nord-Pas de Calais region of northern France.</ArticleTitle><Pagination><MedlinePgn>114-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejogrb.2013.05.025</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0301-2115(13)00256-X</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">During the 2009-2010 influenza A variant virus (A(H1N1)v) pandemic in France, a national pharmacovigilance program was set up to monitor vaccinated, pregnant women, especially the reactogenicity of the vaccine and its impact on the outcome of pregnancy and on the newborn. Here, we present the results for the cohort of pregnant women constituted in the Nord-Pas de Calais region of northern France.</AbstractText><AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">Vaccinated pregnant women were included in the study by the region's vaccination centers between November 2009 and April 2010.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Eight hundred and six pregnant women were included and 781 were followed up until delivery. The risk of adverse events after vaccination and the maternal, fetal and neonatal medical conditions in our cohort did not appear different from the risk observed in the general population.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Our results suggest that A(H1N1)v vaccination of pregnant women did not have an adverse impact on the pregnancies' course and outcome.</AbstractText><CopyrightInformation>Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Auffret</LastName><ForeName>Marine</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Regional Center of Pharmacovigilance, CRPV, Service de Pharmacologie, CHRU de Lille - 1, place de Verdun, 59045 Lille Cedex, France. 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Sophie" uniqKey="Moreau Crepeaux S" first="Sophie" last="Moreau-Crépeaux">Sophie Moreau-Crépeaux</name></noCountry><country name="France"><region name="Hauts-de-France"><name sortKey="Auffret, Marine" sort="Auffret, Marine" uniqKey="Auffret M" first="Marine" last="Auffret">Marine Auffret</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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