title: Safety of high dose trivalent inactivated influenza vaccine in pediatric patients with acute lymphoblastic leukemia.
abstract: BACKGROUND
  Although children with acute lymphoblastic leukemia (ALL) mount immune responses after vaccination with the trivalent influenza vaccine (TIV), these responses are lower compared to controls. Recently, a high dose (HD) TIV was found to increase the level of antibody response in elderly patients compared to the standard dose (SD) TIV. We hypothesized that the HD TIV would be well-tolerated and more immunogenic compared to the SD TIV in pediatric subjects with ALL.
  
  
  METHODS
  This was a randomized, double-blind, phase I safety trial comparing the HD to the SD TIV in children with ALL. Our secondary objective was immunogenicity. Subjects were randomized 2:1 to receive either the HD (60 µg) or the SD (15 µg) TIV. Local and systemic reactions were solicited, hemagglutinin inhibition titers to influenza virus antigens were measured, and monitoring labs were collected prior to and/or after each vaccination.
  
  
  RESULTS
  Fifty subjects were enrolled (34 HD, 16 SD). Mean age was 8.5 years; 63% were male, and 80% were in maintenance therapy. There were no significant differences reported in local or systemic symptoms. No severe adverse events were attributed to vaccination. No significant differences between the HD and SD TIV groups were noted for immune responses.
  
  
  CONCLUSIONS
  No differences were noted between the HD and SD TIV groups for solicited systemic and local reactions. Since this study was not powered for immunogenicity, a phase II trial is needed to determine the immunogenicity of HD versus SD TIV in the pediatric ALL population.
authors.affiliation: Department of Pediatrics, Division of Hematology/BMT, University of Utah School of Medicine/Primary Children's Hospital, Salt Lake City, Utah.
authors.forename: Meghann
authors.initials: M
authors.lastname: McManus
authors.forename: Haydar
authors.initials: H
authors.lastname: Frangoul
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: McCullers
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.forename: Alice
authors.initials: A
authors.lastname: O'Shea
authors.forename: Natasha
authors.initials: N
authors.lastname: Halasa
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D007273:Injections, Intramuscular; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D011379:Prognosis; D012307:Risk Factors; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: children; influenza; leukemia; trivalent inactivated influenza vaccine