Adjuvanted A/H1N1 (2009) influenza vaccination during pregnancy: description of a prospective cohort and spontaneously reported pregnancy-related adverse reactions in the Netherlands.
Identifieur interne : 000130 ( Main/Exploration ); précédent : 000129; suivant : 000131Adjuvanted A/H1N1 (2009) influenza vaccination during pregnancy: description of a prospective cohort and spontaneously reported pregnancy-related adverse reactions in the Netherlands.
Auteurs : Loes De Vries [Pays-Bas] ; Florence Van Hunsel ; Benedikte Cuppers-Maarschalkerweerd ; Eugène Van Puijenbroek ; Kees Van GrootheestSource :
- Birth defects research. Part A, Clinical and molecular teratology [ 1542-0760 ] ; 2014.
Descripteurs français
- KwdFr :
- Complications de la grossesse (induit chimiquement), Complications de la grossesse (épidémiologie), Enquêtes et questionnaires (MeSH), Femelle (MeSH), Grippe humaine (prévention et contrôle), Grippe humaine (épidémiologie), Grossesse (MeSH), Humains (MeSH), Pandémies (prévention et contrôle), Pays-Bas (épidémiologie), Sous-type H1N1 du virus de la grippe A (immunologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Études de cohortes (MeSH), Études prospectives (MeSH).
- MESH :
- effets indésirables : Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux.
- induit chimiquement : Complications de la grossesse.
- prévention et contrôle : Grippe humaine, Pandémies.
- épidémiologie : Complications de la grossesse, Grippe humaine, Pays-Bas.
- Enquêtes et questionnaires, Femelle, Grossesse, Humains, Études de cohortes, Études prospectives.
- Wicri :
- geographic : Pays-Bas.
English descriptors
- KwdEn :
- Cohort Studies (MeSH), Female (MeSH), Humans (MeSH), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (epidemiology), Influenza, Human (prevention & control), Netherlands (epidemiology), Pandemics (prevention & control), Pregnancy (MeSH), Pregnancy Complications (chemically induced), Pregnancy Complications (epidemiology), Prospective Studies (MeSH), Surveys and Questionnaires (MeSH).
- MESH :
- chemical , adverse effects : Influenza Vaccines.
- geographic , epidemiology : Netherlands.
- chemically induced : Pregnancy Complications.
- epidemiology : Influenza, Human, Pregnancy Complications.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- prevention & control : Influenza, Human, Pandemics.
- Cohort Studies, Female, Humans, Pregnancy, Prospective Studies, Surveys and Questionnaires.
Abstract
BACKGROUND
During influenza pandemics, pregnant women have an increased risk of severe complications. Vaccination can diminish these complications. In the Netherlands, the adjuvanted vaccines Focetria® and Pandemrix® were used during the A/H1N1 (2009) influenza pandemic. The national vaccination scheme included pregnant women, but knowledge concerning the safety of adjuvants during pregnancy was lacking. The aim of the study is to assess safety of adjuvanted influenza vaccines during pregnancy.
METHODS
The Dutch Teratology Information Service, part of the Netherlands Pharmacovigilance Centre Lareb, recruited 295 A/H1N1 (2009) vaccinated pregnant women through health care providers. Questionnaires were sent during the pregnancy to their health care providers and a second one 6 weeks after the estimated date of birth. Reported complications and adverse outcomes were compared with background rates. Additionally, the spontaneously reported pregnancy-related adverse reactions in the database of the Netherlands Pharmacovigilance Centre Lareb are described.
RESULTS
Compared with the background rate, no increased risk of spontaneous abortions or congenital malformations was observed. There were three spontaneous abortions among 23 first trimester exposures. In the cohort of 281 pregnancies with known outcomes, three major malformations were observed after exposure at any time during pregnancy. In these cases exposure occurred once periconceptional, and twice in the second trimester. Furthermore, no increased risk of adverse pregnancy outcomes or neonatal problems were observed. The spontaneously reported pregnancy-related adverse events showed no unexpected pattern.
CONCLUSION
The present study adds further reassurance for the safe use of adjuvanted vaccines during pregnancy and facilitates decision making in future pandemics.
DOI: 10.1002/bdra.23243
PubMed: 24706475
Affiliations:
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Part A, Clinical and molecular teratology</title><idno type="eISSN">1542-0760</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cohort Studies (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Influenza A Virus, H1N1 Subtype (immunology)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (epidemiology)</term><term>Influenza, Human (prevention & control)</term><term>Netherlands (epidemiology)</term><term>Pandemics (prevention & control)</term><term>Pregnancy (MeSH)</term><term>Pregnancy Complications (chemically induced)</term><term>Pregnancy Complications (epidemiology)</term><term>Prospective Studies (MeSH)</term><term>Surveys and Questionnaires (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Complications de la grossesse (induit chimiquement)</term><term>Complications de la grossesse (épidémiologie)</term><term>Enquêtes et questionnaires (MeSH)</term><term>Femelle (MeSH)</term><term>Grippe humaine (prévention et contrôle)</term><term>Grippe humaine (épidémiologie)</term><term>Grossesse (MeSH)</term><term>Humains (MeSH)</term><term>Pandémies (prévention et contrôle)</term><term>Pays-Bas (épidémiologie)</term><term>Sous-type H1N1 du virus de la grippe A (immunologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>Études de cohortes (MeSH)</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" qualifier="epidemiology" xml:lang="en"><term>Netherlands</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Pregnancy Complications</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Influenza, Human</term><term>Pregnancy Complications</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H1N1 du virus de la grippe A</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Complications de la grossesse</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term><term>Pandemics</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Grippe humaine</term><term>Pandémies</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Complications de la grossesse</term><term>Grippe humaine</term><term>Pays-Bas</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Cohort Studies</term><term>Female</term><term>Humans</term><term>Pregnancy</term><term>Prospective Studies</term><term>Surveys and Questionnaires</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Enquêtes et questionnaires</term><term>Femelle</term><term>Grossesse</term><term>Humains</term><term>Études de cohortes</term><term>Études prospectives</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Pays-Bas</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>During influenza pandemics, pregnant women have an increased risk of severe complications. Vaccination can diminish these complications. In the Netherlands, the adjuvanted vaccines Focetria® and Pandemrix® were used during the A/H1N1 (2009) influenza pandemic. The national vaccination scheme included pregnant women, but knowledge concerning the safety of adjuvants during pregnancy was lacking. The aim of the study is to assess safety of adjuvanted influenza vaccines during pregnancy.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>The Dutch Teratology Information Service, part of the Netherlands Pharmacovigilance Centre Lareb, recruited 295 A/H1N1 (2009) vaccinated pregnant women through health care providers. Questionnaires were sent during the pregnancy to their health care providers and a second one 6 weeks after the estimated date of birth. Reported complications and adverse outcomes were compared with background rates. Additionally, the spontaneously reported pregnancy-related adverse reactions in the database of the Netherlands Pharmacovigilance Centre Lareb are described.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Compared with the background rate, no increased risk of spontaneous abortions or congenital malformations was observed. There were three spontaneous abortions among 23 first trimester exposures. In the cohort of 281 pregnancies with known outcomes, three major malformations were observed after exposure at any time during pregnancy. In these cases exposure occurred once periconceptional, and twice in the second trimester. Furthermore, no increased risk of adverse pregnancy outcomes or neonatal problems were observed. The spontaneously reported pregnancy-related adverse events showed no unexpected pattern.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>The present study adds further reassurance for the safe use of adjuvanted vaccines during pregnancy and facilitates decision making in future pandemics.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24706475</PMID><DateCompleted><Year>2015</Year><Month>06</Month><Day>25</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1542-0760</ISSN><JournalIssue CitedMedium="Internet"><Volume>100</Volume><Issue>10</Issue><PubDate><Year>2014</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Birth defects research. Part A, Clinical and molecular teratology</Title><ISOAbbreviation>Birth Defects Res. Part A Clin. Mol. Teratol.</ISOAbbreviation></Journal><ArticleTitle>Adjuvanted A/H1N1 (2009) influenza vaccination during pregnancy: description of a prospective cohort and spontaneously reported pregnancy-related adverse reactions in the Netherlands.</ArticleTitle><Pagination><MedlinePgn>731-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/bdra.23243</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">During influenza pandemics, pregnant women have an increased risk of severe complications. Vaccination can diminish these complications. In the Netherlands, the adjuvanted vaccines Focetria® and Pandemrix® were used during the A/H1N1 (2009) influenza pandemic. The national vaccination scheme included pregnant women, but knowledge concerning the safety of adjuvants during pregnancy was lacking. The aim of the study is to assess safety of adjuvanted influenza vaccines during pregnancy.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The Dutch Teratology Information Service, part of the Netherlands Pharmacovigilance Centre Lareb, recruited 295 A/H1N1 (2009) vaccinated pregnant women through health care providers. Questionnaires were sent during the pregnancy to their health care providers and a second one 6 weeks after the estimated date of birth. Reported complications and adverse outcomes were compared with background rates. Additionally, the spontaneously reported pregnancy-related adverse reactions in the database of the Netherlands Pharmacovigilance Centre Lareb are described.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Compared with the background rate, no increased risk of spontaneous abortions or congenital malformations was observed. There were three spontaneous abortions among 23 first trimester exposures. In the cohort of 281 pregnancies with known outcomes, three major malformations were observed after exposure at any time during pregnancy. In these cases exposure occurred once periconceptional, and twice in the second trimester. Furthermore, no increased risk of adverse pregnancy outcomes or neonatal problems were observed. The spontaneously reported pregnancy-related adverse events showed no unexpected pattern.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The present study adds further reassurance for the safe use of adjuvanted vaccines during pregnancy and facilitates decision making in future pandemics.</AbstractText><CopyrightInformation>© 2014 Wiley Periodicals, Inc.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>de Vries</LastName><ForeName>Loes</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>van Hunsel</LastName><ForeName>Florence</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Cuppers-Maarschalkerweerd</LastName><ForeName>Benedikte</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>van 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UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009426" MajorTopicYN="N" Type="Geographic">Netherlands</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011247" MajorTopicYN="N">Pregnancy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011248" MajorTopicYN="N">Pregnancy Complications</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName 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PubStatus="pubmed"><Year>2014</Year><Month>4</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>6</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24706475</ArticleId><ArticleId IdType="doi">10.1002/bdra.23243</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Pays-Bas</li></country></list><tree><noCountry><name sortKey="Cuppers Maarschalkerweerd, Benedikte" sort="Cuppers Maarschalkerweerd, Benedikte" uniqKey="Cuppers Maarschalkerweerd B" first="Benedikte" last="Cuppers-Maarschalkerweerd">Benedikte Cuppers-Maarschalkerweerd</name><name sortKey="Van Grootheest, Kees" sort="Van Grootheest, Kees" uniqKey="Van Grootheest K" first="Kees" last="Van Grootheest">Kees Van Grootheest</name><name sortKey="Van Hunsel, Florence" sort="Van Hunsel, Florence" uniqKey="Van Hunsel F" first="Florence" last="Van Hunsel">Florence Van Hunsel</name><name sortKey="Van Puijenbroek, Eugene" sort="Van Puijenbroek, Eugene" uniqKey="Van Puijenbroek E" first="Eugène" last="Van Puijenbroek">Eugène Van Puijenbroek</name></noCountry><country name="Pays-Bas"><noRegion><name sortKey="De Vries, Loes" sort="De Vries, Loes" uniqKey="De Vries L" first="Loes" last="De Vries">Loes De Vries</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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