Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study.
(Clinical Trial;Journal Article;Multicenter Study)
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.
Gorse, GJ; O'Connor, TZ; Young, SL; Mendelman, PM; Bradley, SF; Nichol, KL; Strickland, JH; Paulson, DM; Rice, KL; Foster, RA; Fulambarker, AM; Shigeoka, JW; Kuschner, WG; Goodman, RP; Neuzil, KM; Wittes, J; Boardman, KD; Peduzzi, PN
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