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 : 001B75 ( PascalFrancis/Curation ); précédent : 001B74; suivant : 001B76The 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.
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<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>
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<fA11 i1="20" i2="1"><s1>CASTOT (A.)</s1>
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<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>
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<fA43 i1="01"><s1>INIST</s1>
<s2>21755</s2>
<s5>354000504190020070</s5>
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<fA44><s0>0000</s0>
<s1>© 2013 INIST-CNRS. All rights reserved.</s1>
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<fA45><s0>33 ref.</s0>
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<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
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<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>
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<fN21><s1>238</s1>
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