Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen, Denmark.
BMJ. 2012 May 2;344:e2794. doi: 10.1136/bmj.e2794.
To investigate whether an adjuvanted pandemic A/H1N1 2009 influenza vaccine in pregnancy was associated with an increased risk of fetal death.
Nationwide register based cohort study.
Denmark.
All clinically recognised singleton pregnancies that ended between November 2009 and September 2010. Individual level data on exposure to an inactivated AS03 pandemic A/H1N1 2009 influenza vaccine (Pandemrix) and potential confounders were linked to the study cohort using a unique person identifier.
The primary outcome measure was risk of fetal death (spontaneous abortion and stillbirth combined) in H1N1 vaccinated compared with unvaccinated pregnancies, adjusting for propensity scores. Secondary outcome measures were spontaneous abortion (between seven and 22 weeks' gestation) and stillbirth (after 22 completed weeks' gestation).
The cohort comprised 54,585 pregnancies; 7062 (12.9%) women were vaccinated against pandemic A/H1N1 2009 influenza during pregnancy. Overall, 1818 fetal deaths occurred (1678 spontaneous abortions and 140 stillbirths). Exposure to the H1N1 vaccine was not associated with an increased risk of fetal death (adjusted hazard ratio 0.79, 95% confidence interval 0.53 to 1.16), or the secondary outcomes of spontaneous abortion (1.11, 0.71 to 1.73) and stillbirth (0.44, 0.20 to 0.94). Estimates for fetal death were similar in pregnant women with (0.82, 0.44 to 1.53) and without comorbidities (0.77, 0.47 to 1.25).
This large cohort study found no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy.
研究孕期接种含佐剂的大流行性 A/H1N1 2009 流感疫苗是否与胎儿死亡风险增加相关。
全国基于登记的队列研究。
丹麦。
所有 2009 年 11 月至 2010 年 9 月间临床确诊的单胎妊娠，个体水平的数据包括暴露于灭活 AS03 大流行性 A/H1N1 2009 流感疫苗（Pandemrix）和潜在混杂因素，使用唯一的个人识别码与研究队列相链接。
主要观察指标是大流行性 A/H1N1 疫苗接种组与未接种组相比，妊娠期间胎儿死亡（包括自然流产和死产）的风险，调整了倾向评分。次要观察指标为自然流产（7-22 孕周）和死产（22 孕周后）。
该队列包括 54585 例妊娠；7062 例（12.9%）孕妇在孕期接种了大流行性 A/H1N1 2009 流感疫苗。共有 1818 例胎儿死亡（1678 例自然流产和 140 例死产）。大流行性 A/H1N1 疫苗的暴露与胎儿死亡风险的增加无关（调整后的危险比为 0.79，95%置信区间为 0.53 至 1.16），也与自然流产（1.11，0.71 至 1.73）和死产（0.44，0.20 至 0.94）的次要结局无关。在有合并症的孕妇（0.82，0.44 至 1.53）和无合并症的孕妇（0.77，0.47 至 1.25）中，胎儿死亡的估计值相似。
这项大型队列研究未发现孕期接种含佐剂的大流行性 A/H1N1 2009 流感疫苗与胎儿死亡风险增加相关的证据。
