Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study

Vaccine. 2003 May 16;21(17-18):2133-44. doi: 10.1016/s0264-410x(02)00748-x.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Administration, Intranasal
  • Aged
  • Disease Outbreaks
  • Humans
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / immunology
  • Influenza Vaccines / therapeutic use*
  • Influenza, Human / epidemiology
  • Influenza, Human / immunology*
  • Injections, Intramuscular
  • Middle Aged
  • Placebos
  • Pulmonary Disease, Chronic Obstructive / complications
  • Pulmonary Disease, Chronic Obstructive / immunology*
  • Reproducibility of Results
  • United States / epidemiology
  • Vaccines, Inactivated / administration & dosage
  • Vaccines, Inactivated / immunology
  • Vaccines, Inactivated / therapeutic use*


  • Influenza Vaccines
  • Placebos
  • Vaccines, Inactivated