title: Infant outcomes after exposure to Tdap vaccine in pregnancy: an observational study.
abstract: OBJECTIVE
  Pertussis vaccination during pregnancy has recently been recommended in both the USA and UK to prevent pertussis infection in infants. While there are no apparent safety concerns about the administration of Tdap vaccine during pregnancy, there is only limited safety data available. We aimed to closely monitor infants exposed to Tdap during pregnancy to look for any adverse outcomes that may be attributable to the vaccine.
  
  
  METHODS
  This was a prospective observational study, collecting information to evaluate the safety of Tdap vaccine for infants exposed during pregnancy. Infants were followed for between 6 and 12 months after birth, with 84% completing 12 months of follow-up. Information was obtained from objective sources including routine health visits and vaccination records wherever possible, as well as frequent parental reports.
  
  
  METHODS
  The Canterbury region of New Zealand.
  
  
  METHODS
  A cohort of 403 infants whose mothers had received Tdap vaccine.
  
  
  METHODS
  Gestational age at birth, growth parameters, congenital anomalies, immunisation status and timeliness of immunisation, development of pertussis infection.
  
  
  RESULTS
  There were no significant differences in birth weight, gestational age at birth, congenital anomalies or infant growth as compared with baseline population data. Infants of mothers who had received the vaccine were more likely to receive their vaccinations on time during infancy. No cases of pertussis occurred in this cohort despite high rates of disease in the community. We have not found any adverse events attributable to vaccine exposure.
  
  
  CONCLUSIONS
  These data add to the growing pool of evidence that the administration of Tdap vaccine during pregnancy is an appropriate strategy for reducing the burden of pertussis in infants.
  
  
  BACKGROUND
  Australia New Zealand Clinical Trials Registry ACTRN12613001045707.
authors.affiliation: Department of Paediatrics, University of Otago, Christchurch, New Zealand.
authors.forename: Tony
authors.initials: T
authors.lastname: Walls
authors.affiliation: Department of Paediatrics, University of Otago, Christchurch, New Zealand Canterbury District Health Board, Christchurch, New Zealand.
authors.forename: Patricia
authors.initials: P
authors.lastname: Graham
authors.affiliation: Department of General Practice and Primary Health Care, University of Auckland, Auckland, New Zealand.
authors.forename: Helen
authors.initials: H
authors.lastname: Petousis-Harris
authors.affiliation: Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.
authors.forename: Linda
authors.initials: L
authors.lastname: Hill
authors.affiliation: Department of Paediatrics, University of Otago, Christchurch, New Zealand Canterbury District Health Board, Christchurch, New Zealand.
authors.forename: Nicola
authors.initials: N
authors.lastname: Austin
mesh_terms: D000328:Adult; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D011247:Pregnancy; D011295:Prenatal Care; D011446:Prospective Studies; D014611:Vaccination / Q000009:adverse effects; D014612:Vaccines / Q000009:adverse effects; D014917:Whooping Cough / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D014612:Vaccines
keywords: INFECTIOUS DISEASES; PUBLIC HEALTH