title: Efficacy and safety of a live attenuated, cold-adapted influenza vaccine, trivalent against culture-confirmed influenza in young children in Asia.
abstract: BACKGROUND
  This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia.
  
  
  METHODS
  In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally > or =28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo.
  
  
  RESULTS
  Mean age at enrollment was 23.5 +/- 7.4 months. In year 1, efficacy of CAIV-T compared with placebo was 72.9% [95% confidence interval (CI): 62.8-80.5%] against antigenically similar influenza subtypes, and 70.1% (95% CI: 60.9-77.3%) against any strain. In year 2, revaccination with CAIV-T demonstrated significant efficacy against antigenically similar (84.3%; 95% CI: 70.1-92.4%) and any (64.2%; 95% CI: 44.2-77.3%) influenza strains. In year 1, fever, runny nose/nasal congestion, decreased activity and appetite, and use of fever medication were more frequent with CAIV-T after dose 1. Runny nose/nasal congestion after dose 2 (year 1) and dose 3 (year 2) and use of fever medication after dose 3 (year 2) were the only other events reported significantly more frequently in CAIV-T recipients.
  
  
  CONCLUSIONS
  CAIV-T was well tolerated and effective in preventing culture-confirmed influenza illness over multiple and complex influenza seasons in young children in Asia.
authors.affiliation: Department of Microbiology and Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. tamj1@wyeth.com
authors.forename: John S
authors.initials: JS
authors.lastname: Tam
authors.forename: Maria Rosario Z
authors.initials: MR
authors.lastname: Capeding
authors.forename: Lucy Chai See
authors.initials: LC
authors.lastname: Lum
authors.forename: Tawee
authors.initials: T
authors.lastname: Chotpitayasunondh
authors.forename: Zaifang
authors.initials: Z
authors.lastname: Jiang
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Huang
authors.forename: Bee Wah
authors.initials: BW
authors.lastname: Lee
authors.forename: Yuan
authors.initials: Y
authors.lastname: Qian
authors.forename: Rudiwilai
authors.initials: R
authors.lastname: Samakoses
authors.forename: Somsak
authors.initials: S
authors.lastname: Lolekha
authors.forename: K Pillai
authors.initials: KP
authors.lastname: Rajamohanan
authors.forename: S Noel
authors.initials: SN
authors.lastname: Narayanan
authors.forename: Chellam
authors.initials: C
authors.lastname: Kirubakaran
authors.forename: Ruth
authors.initials: R
authors.lastname: Rappaport
authors.forename: Ahmad
authors.initials: A
authors.lastname: Razmpour
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Forrest
mesh_terms: D000222:Adaptation, Physiological; D001208:Asia / Q000453:epidemiology; D002675:Child, Preschool; D003080:Cold Temperature; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D009975:Orthomyxoviridae / Q000276:immunology* / Q000502:physiology; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology*
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated