2013
DOI: 10.1586/17512433.2013.811817
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Assessing vaccine efficacy in influenza clinical trials: challenges and difficulties

Abstract: The efficacy assessment of an influenza vaccine often requires conducting large and expensive clinical trials. Specificities of influenza increase the complexity of the study designs, of the subsequent statistical analysis and of the interpretation of the results. They include low attack rates, seasonality, multiplicity and frequent mutations of flu viruses as well as heterogeneity of virus circulation, varying annual vaccine composition and so on. The authors discuss how those factors may impact the design, t… Show more

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Cited by 4 publications
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“…However, we should point out that the classification adopted is a working one, since, for example, diabetes and intravenous drug use may also be seen as immunosuppressive conditions; we split these conditions into single categories on account of their particular public health burden. The number of the IV-related studies included in each SR/SRMA was highly skewed (range: 1-209) and presented a median of 15 (interquartile range: [9][10][11][12][13][14][15][16][17][18]. With regard to the quality of reporting, no SR/SRMA met all 16 AMSTAR-2 criteria ( Table 1).…”
Section: Selection Process and Main Characteristics Of The Systematicmentioning
confidence: 99%
“…However, we should point out that the classification adopted is a working one, since, for example, diabetes and intravenous drug use may also be seen as immunosuppressive conditions; we split these conditions into single categories on account of their particular public health burden. The number of the IV-related studies included in each SR/SRMA was highly skewed (range: 1-209) and presented a median of 15 (interquartile range: [9][10][11][12][13][14][15][16][17][18]. With regard to the quality of reporting, no SR/SRMA met all 16 AMSTAR-2 criteria ( Table 1).…”
Section: Selection Process and Main Characteristics Of The Systematicmentioning
confidence: 99%