Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.
The Netherlands Perinatal Registry, Utrecht, the Netherlands.
BJOG. 2016 Apr;123(5):709-17. doi: 10.1111/1471-0528.13329. Epub 2015 Mar 6.
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.
Cross-sectional linkage study.
A sample of pregnant women, eligible for prenatal screening, were invited to participate.
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.
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.
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.
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.
No increased risk for adverse pregnancy outcomes and infant's health following influenza vaccination.
本研究旨在评估在妊娠第二和第三 trimester 接种含有 MF59 和硫柳汞的流感 A(H1N1)疫苗的安全性，通过妊娠结局和婴儿健康来衡量。
横断面连锁研究。
邀请了有资格进行产前筛查的孕妇参加。
问卷调查数据与荷兰围产期登记处（n=1920）相关联。获得了 1739 名婴儿的生长发育信息（n=1739）和 1671 名婴儿在生命第一年与全科医生（GP）的感染相关接触信息。
采用多变量逻辑回归分析评估 H1N1 疫苗接种与小于胎龄儿、早产和复合不良结局（即低 Apgar 评分、新生儿重症监护病房入院、新生儿复苏或围产期死亡）之间的关联。采用多变量线性混合模型和多变量负二项回归分别评估母亲疫苗接种对生长发育和 GP 感染相关接触率的影响。
应答率为 21%。尽管我们发现未接种疫苗和接种疫苗的女性在特征上存在差异，但在多变量分析中，H1N1 疫苗接种与小于胎龄儿（比值比[OR]0.84；95%置信区间[95%CI]0.50-1.43）、早产（OR 0.98；95%CI 0.59-1.62）和复合不良结局（OR 0.84；95%CI 0.44-1.60）之间均无关联。我们发现体重与年龄的比值（-0.05；95%CI-0.13 至 0.04）、身长与年龄的比值（-0.01；95%CI-0.09 至 0.06）、头围与年龄的比值（-0.05；95%CI-0.13 至 0.03）、发育评分（-0.06；95%CI-0.28 至 0.17）和婴儿感染相关 GP 接触率（发病率比 1.07；95%CI 0.91-1.28）在未接种疫苗和接种疫苗的母亲的婴儿之间均无差异。
H1N1 疫苗接种与未接种疫苗的女性的妊娠结局无差异。此外，在生命的第一年之后评估的生长、发育和与 GP 感染相关的接触率在接种疫苗和未接种疫苗的母亲的后代中相似。
流感疫苗接种后妊娠结局和婴儿健康无增加风险。
