流感妈妈：一项针对母婴对的前瞻性队列研究，评估母亲接种流感疫苗在预防婴儿早期流感方面的有效性。
FluMum: a prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in prevention of influenza in early infancy.
作者信息
O'Grady Kerry-Ann F, McHugh Lisa, Nolan Terry, Richmond Peter, Wood Nicholas, Marshall Helen S, Lambert Stephen B, Chatfield Mark, Andrews Ross M
机构信息
Queensland Children's Medical Research Institute, Queensland University of Technology, Herston, Queensland, Australia.
Queensland Children's Medical Research Institute, The University of Queensland Herston, Queensland, Australia Communicable Diseases Unit, Queensland Health, Herston, Queensland, Australia National Centre for Epidemiology & Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.
出版信息
BMJ Open. 2014 Jun 24;4(6):e005676. doi: 10.1136/bmjopen-2014-005676.
INTRODUCTION
Influenza vaccination in pregnancy is recommended for all women in Australia, particularly those who will be in their second or third trimester during the influenza season. However, there has been no systematic monitoring of influenza vaccine uptake among pregnant women in Australia. Evidence is emerging of benefit to the infant with respect to preventing influenza infection in the first 6 months of life. The FluMum study aims to systematically monitor influenza vaccine uptake during pregnancy in Australia and determine the effectiveness of maternal vaccination in preventing laboratory-confirmed influenza in their offspring up to 6 months of age.
METHODS AND ANALYSIS
A prospective cohort study of 10 106 mother-infant pairs recruited between 38 weeks gestation and 55 days postdelivery in six Australian capital cities. Detailed maternal and infant information is collected at enrolment, including influenza illness and vaccination history with a follow-up data collection time point at infant age 6 months. The primary outcome is laboratory-confirmed influenza in the infant. Case ascertainment occurs through searches of Australian notifiable diseases data sets once the infant turns 6 months of age (with parental consent). The primary analysis involves calculating vaccine effectiveness against laboratory-confirmed influenza by comparing the incidence of influenza in infants of vaccinated mothers to the incidence in infants of unvaccinated mothers. Secondary analyses include annual and pooled estimates of the proportion of mothers vaccinated during pregnancy, the effectiveness of maternal vaccination in preventing hospitalisation for acute respiratory illness and modelling to assess the determinants of vaccination.
ETHICS AND DISSEMINATION
The study was approved by all institutional Human Research Ethics Committees responsible for participating sites. Study findings will be published in peer review journals and presented at national and international conferences.
TRIAL REGISTRATION NUMBER
The study is registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR) number: 12612000175875.
引言
澳大利亚建议所有孕妇接种流感疫苗，尤其是那些在流感季节处于孕中期或孕晚期的孕妇。然而，澳大利亚尚未对孕妇流感疫苗接种情况进行系统监测。越来越多的证据表明，接种流感疫苗对预防婴儿出生后头6个月内感染流感有益。“流感妈妈”研究旨在系统监测澳大利亚孕妇流感疫苗接种情况，并确定母亲接种疫苗对预防其6个月龄以下后代实验室确诊流感的有效性。
方法与分析
对澳大利亚六个首府城市中在妊娠38周和产后55天之间招募的10106对母婴进行前瞻性队列研究。在入组时收集详细的母婴信息，包括流感疾病和疫苗接种史，并在婴儿6个月龄时进行随访数据收集。主要结局是婴儿实验室确诊的流感。在婴儿满6个月后（经父母同意），通过搜索澳大利亚法定传染病数据集来确定病例。主要分析包括通过比较接种疫苗母亲的婴儿流感发病率与未接种疫苗母亲的婴儿流感发病率，计算疫苗对实验室确诊流感的有效性。次要分析包括每年和汇总估计孕期接种疫苗的母亲比例、母亲接种疫苗预防急性呼吸道疾病住院的有效性以及评估疫苗接种决定因素的模型。
伦理与传播
该研究已获得负责参与研究地点的所有机构人类研究伦理委员会的批准。研究结果将发表在同行评审期刊上，并在国内和国际会议上展示。
试验注册号
该研究已在澳大利亚和新西兰临床试验注册中心（ANZCTR）注册，注册号为：12612000175875。
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