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Safety of vaccination against influenza A (H1N1) during pregnancy in the Netherlands: results on pregnancy outcomes and infant's health: cross-sectional linkage study.

Identifieur interne : 000067 ( Main/Exploration ); précédent : 000066; suivant : 000068

Safety of vaccination against influenza A (H1N1) during pregnancy in the Netherlands: results on pregnancy outcomes and infant's health: cross-sectional linkage study.

Auteurs : N. Van Der Maas [Pays-Bas] ; J. Dijs-Elsinga [Pays-Bas] ; J. Kemmeren [Pays-Bas] ; A. Van Lier [Pays-Bas] ; M. Knol [Pays-Bas] ; H. De Melker [Pays-Bas]

Source :

RBID : pubmed:25754741

Descripteurs français

English descriptors

Abstract

OBJECTIVE

This study aims to assess the safety of Influenza A(H1N1), vaccination administered during the second and third trimester and containing MF59 and thiomersal (Focetria(®) ), measured by pregnancy outcomes and infant's health.

DESIGN

Cross-sectional linkage study.

SETTING AND SAMPLE

A sample of pregnant women, eligible for prenatal screening, were invited to participate.

METHODS

Questionnaire data were linked with the Netherlands Perinatal Registry (n = 1920). Information on infant growth, development (n = 1739) and infection-related contacts with the general practitioner (GP) during the first year of life (n = 1671) was obtained.

MAIN OUTCOME MEASURES

Multivariate logistic regression was used to assess the association between H1N1 vaccination and small-for-gestational-age infant, preterm delivery and a composite adverse outcome, i.e. low Apgar-score, neonatal intensive care unit admission, neonatal resuscitation or perinatal death. Influence of maternal vaccination on growth, development and GP infection-related contact rates were assessed using multivariate linear mixed modelling and multivariate negative binomial regression, respectively.

RESULTS

Response rate was 21%. Though we found differences in characteristics between unvaccinated and vaccinated women, in the multivariate analyses no association was found between H1N1 vaccination and small-for-gestational-age (odds ratio [OR] 0.84; 95% confidence interval [95% CI] 0.50-1.43), preterm delivery (OR 0.98; 95% CI 0.59-1.62) and the composite adverse outcome (OR 0.84; 95% CI 0.44-1.60). We found no differences in weight-for-age (-0.05; 95% CI -0.13 to 0.04), length-for-age (-0.01; 95% CI -0.09 to 0.06), head-circumference-for-age (-0.05; 95% CI -0.13 to 0.03), developmental scores (-0.06; 95% CI -0.28 to 0.17) and infection-related GP contact rates (incidence rate ratio 1.07; 95% CI 0.91-1.28) between infants of unvaccinated and vaccinated mothers.

CONCLUSION

Pregnancy outcomes did not differ between H1N1-vaccinated and unvaccinated women. Furthermore, growth, development and GP infection-related contact rates, assessed after the first year of life, were similar in offspring of vaccinated and unvaccinated mothers.

TWEETABLE ABSTRACT

No increased risk for adverse pregnancy outcomes and infant's health following influenza vaccination.


DOI: 10.1111/1471-0528.13329
PubMed: 25754741


Affiliations:


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Le document en format XML

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<term>Humans (MeSH)</term>
<term>Infant (MeSH)</term>
<term>Infant Health (MeSH)</term>
<term>Infant, Newborn (MeSH)</term>
<term>Influenza A Virus, H1N1 Subtype (MeSH)</term>
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<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza, Human (prevention & control)</term>
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<term>Logistic Models (MeSH)</term>
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<term>Enquêtes de santé (MeSH)</term>
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<term>Grippe humaine (prévention et contrôle)</term>
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<term>Humains (MeSH)</term>
<term>Issue de la grossesse (MeSH)</term>
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<term>Nouveau-né (MeSH)</term>
<term>Pays-Bas (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Santé infantile (MeSH)</term>
<term>Sous-type H1N1 du virus de la grippe A (MeSH)</term>
<term>Vaccins antigrippaux (administration et posologie)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
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<term>Influenza Vaccines</term>
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<term>Vaccins antigrippaux</term>
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<term>Pregnancy Complications, Infectious</term>
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<term>Complications infectieuses de la grossesse</term>
<term>Grippe humaine</term>
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<term>Cross-Sectional Studies</term>
<term>Female</term>
<term>Health Surveys</term>
<term>Humans</term>
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<term>Infant Health</term>
<term>Infant, Newborn</term>
<term>Influenza A Virus, H1N1 Subtype</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVE</b>
</p>
<p>This study aims to assess the safety of Influenza A(H1N1), vaccination administered during the second and third trimester and containing MF59 and thiomersal (Focetria(®) ), measured by pregnancy outcomes and infant's health.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>DESIGN</b>
</p>
<p>Cross-sectional linkage study.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>SETTING AND SAMPLE</b>
</p>
<p>A sample of pregnant women, eligible for prenatal screening, were invited to participate.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>Questionnaire data were linked with the Netherlands Perinatal Registry (n = 1920). Information on infant growth, development (n = 1739) and infection-related contacts with the general practitioner (GP) during the first year of life (n = 1671) was obtained.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>MAIN OUTCOME MEASURES</b>
</p>
<p>Multivariate logistic regression was used to assess the association between H1N1 vaccination and small-for-gestational-age infant, preterm delivery and a composite adverse outcome, i.e. low Apgar-score, neonatal intensive care unit admission, neonatal resuscitation or perinatal death. Influence of maternal vaccination on growth, development and GP infection-related contact rates were assessed using multivariate linear mixed modelling and multivariate negative binomial regression, respectively.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>Response rate was 21%. Though we found differences in characteristics between unvaccinated and vaccinated women, in the multivariate analyses no association was found between H1N1 vaccination and small-for-gestational-age (odds ratio [OR] 0.84; 95% confidence interval [95% CI] 0.50-1.43), preterm delivery (OR 0.98; 95% CI 0.59-1.62) and the composite adverse outcome (OR 0.84; 95% CI 0.44-1.60). We found no differences in weight-for-age (-0.05; 95% CI -0.13 to 0.04), length-for-age (-0.01; 95% CI -0.09 to 0.06), head-circumference-for-age (-0.05; 95% CI -0.13 to 0.03), developmental scores (-0.06; 95% CI -0.28 to 0.17) and infection-related GP contact rates (incidence rate ratio 1.07; 95% CI 0.91-1.28) between infants of unvaccinated and vaccinated mothers.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSION</b>
</p>
<p>Pregnancy outcomes did not differ between H1N1-vaccinated and unvaccinated women. Furthermore, growth, development and GP infection-related contact rates, assessed after the first year of life, were similar in offspring of vaccinated and unvaccinated mothers.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TWEETABLE ABSTRACT</b>
</p>
<p>No increased risk for adverse pregnancy outcomes and infant's health following influenza vaccination.</p>
</div>
</front>
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<CitationSubset>AIM</CitationSubset>
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<Keyword MajorTopicYN="N">Infant</Keyword>
<Keyword MajorTopicYN="N">influenza</Keyword>
<Keyword MajorTopicYN="N">pregnancy</Keyword>
<Keyword MajorTopicYN="N">safety</Keyword>
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<Year>2015</Year>
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<name sortKey="De Melker, H" sort="De Melker, H" uniqKey="De Melker H" first="H" last="De Melker">H. De Melker</name>
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