IIV-HD was significantly more effective than IIV-SD in preventing SAEs possibly related to influenza overall (rVE, 17.7% 95% confidence interval, 6.6-27.4%) and serious pneumonia (rVE, 39.8% 95% CI, 19.3-55.1%). Relative vaccine effectiveness (rVE) was estimated as (1-Rate Ratio)×100.ģ1,989 participants were enrolled, with 15,991 and 15,998 randomized to receive IIV-HD and IIV-SD, respectively. For the present analysis, reported SAEs were classified as possibly related to influenza by three blinded physicians and rates per 1000 participant-seasons were calculated. SAEs were events: leading to death or hospitalization (or its prolongation) considered life-threatening or medically important or resulting in disability. Participants were adults ≥65 years randomized to receive IIV-HD or IIV-SD, and followed for 6-8 months post-vaccination for the occurrence of influenza and serious adverse events (SAEs). The original study was a double-blind, randomized, active-controlled, multicenter trial. Here we evaluate the effectiveness of IIV-HD compared to IIV-SD in preventing serious illnesses considered potential sequelae or complications of influenza infection. A recent study showed that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than a standard-dose inactivated influenza vaccine (IIV-SD) in preventing laboratory-confirmed symptomatic influenza in adults ≥65 years.
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