title: Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial.
abstract: Childhood infections are common and Bacillus Calmette-Guérin (BCG) vaccination at birth may prevent these via nonspecific effects.
  
  
  
  A randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation.
  
  
  
  The analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07).
  
  
  
  This study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.
authors.affiliation: The Department of Paediatrics and Adolescent Medicine, Juliane Marie Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Jesper
authors.initials: J
authors.lastname: Kjærgaard
authors.affiliation: Department of Paediatrics 460, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Nina M
authors.initials: NM
authors.lastname: Birk
authors.affiliation: Department of Paediatrics 460, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Nissen
authors.affiliation: Department of Paediatrics, Kolding Hospital, University of Southern Denmark, Kolding, Denmark.
authors.forename: Lisbeth M
authors.initials: LM
authors.lastname: Thøstesen
authors.affiliation: Department of Paediatrics, Kolding Hospital, University of Southern Denmark, Kolding, Denmark.
authors.forename: Gitte T
authors.initials: GT
authors.lastname: Pihl
authors.affiliation: Research Center for Vitamins and Vaccines (CVIVA), Statens Serum Institut and OPEN, Institute of Clinical Research, University of Southern Denmark/Odense University Hospital, Copenhagen, Denmark.
authors.forename: Christine S
authors.initials: CS
authors.lastname: Benn
authors.affiliation: Department of Paediatrics 460, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Dorthe L
authors.initials: DL
authors.lastname: Jeppesen
authors.affiliation: Department of Paediatrics 460, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Ole
authors.initials: O
authors.lastname: Pryds
authors.affiliation: Department of Paediatrics, Kolding Hospital, University of Southern Denmark, Kolding, Denmark.
authors.forename: Poul-Erik
authors.initials: PE
authors.lastname: Kofoed
authors.affiliation: Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Aaby
authors.affiliation: The Neonatal Department, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Gorm
authors.initials: G
authors.lastname: Greisen
authors.affiliation: The Department of Paediatrics and Adolescent Medicine, Juliane Marie Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: Lone G
authors.initials: LG
authors.lastname: Stensballe
mesh_terms: D001500:BCG Vaccine / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000517:prevention & control*; D003140:Communicable Disease Control; D003718:Denmark; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009169:Mycobacterium tuberculosis; D011247:Pregnancy; D015203:Reproducibility of Results; D013997:Time Factors; D014611:Vaccination
chemical_list: D001500:BCG Vaccine