作者: Carlos A. DiazGranados , Corwin A. Robertson , H. Keipp Talbot , Victoria Landolfi , Andrew J. Dunning
DOI: 10.1016/J.VACCINE.2015.07.006
关键词: Multicenter trial 、 Adverse effect 、 Internal medicine 、 Confidence interval 、 Immunology 、 Medicine 、 Influenza vaccine 、 Pneumonia
摘要: Abstract Background A recent study showed that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than standard-dose (IIV-SD) in preventing laboratory-confirmed symptomatic adults ≥65 years. Here we evaluate the effectiveness of IIV-HD compared to IIV-SD serious illnesses considered potential sequelae or complications infection. Methods The original double-blind, randomized, active-controlled, multicenter trial. Participants were years randomized receive IIV-SD, and followed for 6–8 months post-vaccination occurrence adverse events (SAEs). SAEs events: leading death hospitalization (or its prolongation); life-threatening medically important; resulting disability. For present analysis, reported classified as possibly related by three blinded physicians rates per 1000 participant-seasons calculated. Relative (rVE) estimated (1 − Rate Ratio) × 100. Results 31,989 participants enrolled, with 15,991 15,998 respectively. significantly effective overall (rVE, 17.7%; 95% confidence interval [CI], 6.6–27.4%) pneumonia 39.8%; CI, 19.3–55.1%). Borderline significance observed efficacy relative prevention all-cause hospitalizations 6.9%; 0.5–12.8%). Conclusions Compared reduced risk influenza. against is particularly noteworthy considering burden older adults.