title: FluMum: a prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in prevention of influenza in early infancy.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  The study is registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR) number: 12612000175875.
authors: Queensland Children's Medical Research Institute, Queensland University of Technology, Herston, Queensland, Australia.
authors: Kerry-Ann F
authors: KA
authors: O'Grady
authors: 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.
authors: Lisa
authors: L
authors: McHugh
authors: Vaccine and Immunisation Research Group, Murdoch Children's Research Institute and Melbourne School of Population and Global Health, The University of Melbourne, Victoria, Australia.
authors: Terry
authors: T
authors: Nolan
authors: Vaccine Trials Group, Telethon Institute for Child Health Research, University of Western Australia, Perth, Western Australia, Australia.
authors: Peter
authors: P
authors: Richmond
authors: National Centre for Immunisation Research and Surveillance, University of Sydney, Westmead, New South Wales, Australia.
authors: Nicholas
authors: N
authors: Wood
authors: Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and School of Paediatrics and Reproductive Health and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.
authors: Helen S
authors: HS
authors: Marshall
authors: Queensland Children's Medical Research Institute, The University of Queensland Herston, Queensland, Australia Communicable Diseases Unit, Queensland Health, Herston, Queensland, Australia.
authors: Stephen B
authors: SB
authors: Lambert
authors: Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
authors: Mark
authors: M
authors: Chatfield
authors: Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
authors: Ross M
authors: RM
authors: Andrews
mesh_terms: D001315:Australia; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007252:Influenza Vaccines; D007251:Influenza, Human / Q000517:prevention & control*; D009035:Mothers; D011247:Pregnancy; D011295:Prenatal Care; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D007252:Influenza Vaccines