The PREGVAXGRIP Study: a Cohort Study to Assess Foetal and Neonatal Consequences of In Utero Exposure to Vaccination Against A(H1N1)v2009 Influenza
The PREGVAXGRIP Study: a Cohort Study to Assess Foetal and Neonatal Consequences of In Utero Exposure to Vaccination Against A(H1N1)v2009 Influenza
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DOI：
10.1007/s40264-013-0030-1
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发表时间：
2013-06-01
期刊：
影响因子：
4.2
通讯作者：
Perault-Pochat, M. C.
中科院分区：
文献类型：
--
作者：
Chavant, F.;Ingrand, I.;Perault-Pochat, M. C.
背景2009年10月，在甲型H1N1病毒2009流感大流行的背景下，法国启动了一项疫苗接种运动，其中一个优先群体是孕妇，因为感染该病毒后发生并发症的风险很高。一项观察性研究旨在评估一组接受甲型H1N1流感疫苗的孕妇的安全性和妊娠结局v2009流感大流行疫苗。方法这是一项前瞻性研究，主要是在疫苗接种中心和产科招募的孕妇进行随访。在预产期后，收集有关分娩、婴儿以及（如果适用）未足月妊娠原因的随访数据。结果2009年11月1日至2010年3月31日期间，2，415名孕妇在接种疫苗时被纳入; 97.6%的妇女接种了无佐剂疫苗，2.4%接种了含佐剂疫苗。92名（3.9%）妇女在怀孕前三个月接种了疫苗，1，090名（46.5%）妇女在怀孕中期接种了疫苗，1，162名（49.6%）妇女在怀孕后期接种了疫苗。报告了133起不良事件（5.5%的女性），其中12起为非预期或严重事件。有2，246例（93.0%）已知妊娠结局，其中12例自然流产（0.5%），6例死产（0.3%）和4例治疗性流产（0.2%）。新生儿先天畸形65例，其中31例为重大畸形。但在怀孕前三个月接种疫苗的92名妇女中，只报告了一例先天畸形（1. 4%）。在这些妇女中，93.3%是足月分娩，6.7%是早产。96例（4.2%）新生儿在新生儿期报告了疾病，130例（5.6%）被转移到产科。结论本研究表明，妊娠期间接触甲型H1N1流感疫苗不会增加不良妊娠结局的风险。然而，由于在妊娠早期暴露的妇女人数相对较少，需要进行其他研究以排除畸形风险增加。
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 stillbirths (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.