title: No adverse events after simultaneous administration of 50 000 IU vitamin A and Bacille Calmette-Guerin vaccination to normal-birth-weight newborns in Guinea-Bissau.
abstract: OBJECTIVE
  To determine whether the combined intervention of 50 000 IU vitamin A administered together with Bacille Calmette-Guerin (BCG) vaccination at birth was associated with adverse events, in particular bulging fontanels and adverse reactions to BCG.
  
  
  METHODS
  From an ongoing trial, 2145 infants randomized to 50 000 IU vitamin A or placebo with BCG vaccination were recruited. Adverse events were monitored in two different ways: (A) daily clinical examinations by a medical doctor during the first 3 days post supplementation; (B) weekly interviews by a trained assistant during the first month post supplementation.
  
  
  RESULTS
  In part A, 1271 infants were enrolled, in part B 2078. Vitamin A supplementation (VAS) was associated with a relative risk (RR) of bulging fontanels of 1.16 (95% confidence interval (CI)=0.82-1.65). The rate of health care contacts and various symptoms during the first month were comparable between the groups. VAS was associated with larger peak local reactions to BCG vaccination in boys, but not in girls (P-value for test of interaction between VAS and sex=0.02).
  
  
  CONCLUSIONS
  50 000 IU vitamin A with BCG was not associated with adverse events. The observed sex-differential effect of VAS on local reaction to BCG is in line with other observations of sex-differential effects of VAS.
authors.affiliation: Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.
authors.forename: J E
authors.initials: JE
authors.lastname: Nante
authors.forename: B R
authors.initials: BR
authors.lastname: Diness
authors.forename: H
authors.initials: H
authors.lastname: Ravn
authors.forename: A
authors.initials: A
authors.lastname: Roth
authors.forename: P
authors.initials: P
authors.lastname: Aaby
authors.forename: C S
authors.initials: CS
authors.lastname: Benn
mesh_terms: D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D055762:Cranial Fontanelles / Q000473:pathology*; D004347:Drug Interactions; D005260:Female; D006169:Guinea-Bissau; D006801:Humans; D007115:Immunization Schedule; D007231:Infant, Newborn; D008297:Male; D018570:Risk Assessment; D012737:Sex Factors; D013997:Time Factors; D014376:Tuberculosis / Q000517:prevention & control; D014611:Vaccination / Q000379:methods; D014801:Vitamin A / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D001500:BCG Vaccine; D014801:Vitamin A