title: Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study.
abstract: We assessed whether trivalent live, cold-adapted influenza virus (CAIV-T) vaccine provides added protection when co-administered with trivalent inactivated influenza virus vaccine (TVV) in patients with chronic obstructive pulmonary disease (COPD). Subjects (N=2215) were randomly assigned to receive either TVV intramuscularly (IM) and CAIV-T intranasally (TC), or TVV and placebo (TP). The vaccines were well-tolerated. Efficacy of TC compared to TP was not statistically significant and was 0.16 for any influenza virus strain (95% confidence limit (CL): -0.22, 0.43), 0.26 for A (H3N2) virus (95% CL: -0.17, 0.53), and -0.05 for type B virus (95% CL: -1.13, 0.48). However, there was a possible advantage for TC over TP in reducing respiratory consequences of an influenza season measured by pulmonary function and symptoms at end of study.
authors.affiliation: Department of Veterans Affairs, Medical Center, Saint Louis University, St. Louis, MO, USA. gorsegj@slu.edu
authors.forename: Geoffrey J
authors.initials: GJ
authors.lastname: Gorse
authors.forename: Theresa Z
authors.initials: TZ
authors.lastname: O'Connor
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Young
authors.forename: Paul M
authors.initials: PM
authors.lastname: Mendelman
authors.forename: Suzanne F
authors.initials: SF
authors.lastname: Bradley
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Nichol
authors.forename: James H
authors.initials: JH
authors.lastname: Strickland
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Paulson
authors.forename: Kathryn L
authors.initials: KL
authors.lastname: Rice
authors.forename: Runi A
authors.initials: RA
authors.lastname: Foster
authors.forename: Ashok M
authors.initials: AM
authors.lastname: Fulambarker
authors.forename: John W
authors.initials: JW
authors.lastname: Shigeoka
authors.forename: Ware G
authors.initials: WG
authors.lastname: Kuschner
authors.forename: Richard P
authors.initials: RP
authors.lastname: Goodman
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Neuzil
authors.forename: Janet
authors.initials: J
authors.lastname: Wittes
authors.forename: Kathy D
authors.initials: KD
authors.lastname: Boardman
authors.forename: Peter N
authors.initials: PN
authors.lastname: Peduzzi
mesh_terms: D000281:Administration, Intranasal; D000368:Aged; D004196:Disease Outbreaks; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D007251:Influenza, Human / Q000453:epidemiology / Q000276:immunology*; D007273:Injections, Intramuscular; D008875:Middle Aged; D010919:Placebos; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000276:immunology*; D015203:Reproducibility of Results; D014481:United States / Q000453:epidemiology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D007252:Influenza Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated