MedicalResearch.com Interview with:
Dr Ayman Chit PhD
Sanofi Pasteur
Swiftwater, PA 18370
Medical Research: What is the background for this study? What are the main findings?
Dr. Chit: Our analysis used data from a large-scale, multi-center efficacy trial, in which a higher-dose split-virus inactivated influenza vaccine (IIV-HD, Fluzone
® High-Dose vaccine, Sanofi Pasteur) was compared to a standard-dose split-virus inactivated influenza vaccine (IIV-SD, Fluzone vaccine, Sanofi Pasteur) in persons 65 years of age and older. These data were supplemented with US healthcare cost data.
In the efficacy trial, a total of 31,989 adults 65 years of age and older were randomly assigned in a 1:1 ratio to receive either IIV-HD or IIV-SD and followed for six to eight months post-vaccination for the occurrence of influenza, serious adverse events, and medical encounters. Healthcare utilization (HCU) data were captured for all participants through a surveillance program that covered each influenza season, including the following events occurring within 30 days after any respiratory illness: use of prescription and non-prescription medications (limited to antipyretics/analgesics/non-steroidal anti-inflammatory drugs, antivirals and antibiotics), emergency room visits, non-routine or urgent care visits, and hospitalizations. In addition, all hospitalizations were captured for participants for the entire duration of the study.
The primary results from the efficacy trial were published in
The New England Journal of Medicine, which reported that IIV-HD was 24.2% (95% confidence interval [CI], 9.7% to 36.5%) more effective in preventing laboratory-confirmed
influenza-like illness compared to IIV-SD.
1 In the current supplemental analysis of the trial, we used US healthcare cost data to evaluate economic impacts of using IIV-HD compared to IIV-SD within the efficacy trial participants. In this analysis, total healthcare payer costs (the combined costs of study vaccine, prescription drugs, emergency room visits, non-routine and urgent-care visits, and hospital admissions) were about $116 less per person.
- DiazGranados et al, NEJM, 2014;14;371(7):635-45
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