title: Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial.
abstract: The rates of influenza illness and associated complications are high among children in Bangladesh. We assessed the clinical efficacy and safety of a Russian-backbone live attenuated influenza vaccine (LAIV) at two field sites in Bangladesh.
  
  
  
  Between Feb 27 and April 9, 2013, children aged 2-4 years in urban Kamalapur and rural Matlab, Bangladesh, were randomly assigned in a 2:1 ratio, according to a computer-generated schedule, to receive one intranasal dose of LAIV or placebo. After vaccination, we monitored children in weekly home visits until Dec 31, 2013, with study clinic surveillance for influenza illness. The primary outcome was symptomatic, laboratory-confirmed influenza illness due to vaccine-matched strains. Analysis was per protocol. The trial is registered with ClinicalTrials.gov, number NCT01797029.
  
  
  
  Of 1761 children enrolled, 1174 received LAIV and 587 received placebo. Laboratory-confirmed influenza illness due to vaccine-matched strains was seen in 93 (15·8%) children in the placebo group and 79 (6·7%) in the LAIV group. Vaccine efficacy of LAIV for vaccine-matched strains was 57·5% (95% CI 43·6-68·0). The vaccine was well tolerated, and adverse events were balanced between the groups. The most frequent adverse events were tachypnoea (n=86 in the LAIV group and n=54 in the placebo group), cough (n=73 and n=43), and runny nose (n=68 and n=39), most of which were mild.
  
  
  
  This single-dose Russian-backbone LAIV was safe and efficacious at preventing symptomatic laboratory-confirmed influenza illness due to vaccine-matched strains. LAIV programmes might reduce the burden of influenza illness in Bangladesh.
  
  
  
  The Bill & Melinda Gates Foundation.
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh; International Health, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: W Abdullah
authors.initials: WA
authors.lastname: Brooks
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: K
authors.initials: K
authors.lastname: Zaman
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Kristen D C
authors.initials: KD
authors.lastname: Lewis
authors.affiliation: PATH, Seattle, WA, USA; Departments of Global Health and Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Justin R
authors.initials: JR
authors.lastname: Ortiz
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Doli
authors.initials: D
authors.lastname: Goswami
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Jodi
authors.initials: J
authors.lastname: Feser
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Amina Tahia
authors.initials: AT
authors.lastname: Sharmeen
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Kamrun
authors.initials: K
authors.lastname: Nahar
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Mustafizur
authors.initials: M
authors.lastname: Rahman
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Mohammed Ziaur
authors.initials: MZ
authors.lastname: Rahman
authors.affiliation: The EMMES Corporation, Rockville, MD, USA.
authors.forename: Burc
authors.initials: B
authors.lastname: Barin
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Yunus
authors.affiliation: Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Alicia M
authors.initials: AM
authors.lastname: Fry
authors.affiliation: Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Bresee
authors.affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
authors.forename: Tasnim
authors.initials: T
authors.lastname: Azim
authors.affiliation: PATH, Seattle, WA, USA. Electronic address: kneuzil@medicine.umaryland.edu.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Neuzil
mesh_terms: D000281:Administration, Intranasal / Q000379:methods; D001459:Bangladesh; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017589:Immunization Programs; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D010919:Placebos; D014611:Vaccination / Q000379:methods; D014613:Vaccines, Attenuated / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D007252:Influenza Vaccines; D010919:Placebos; D014613:Vaccines, Attenuated