2013
DOI: 10.1016/s1473-3099(13)70046-x
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AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial

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Cited by 147 publications
(109 citation statements)
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“…33 An observational study in elderly adults in Northern Italy 34 reported a lower rate of influenza-like illness or pneumonia after ADV relative to TIV but only after multiple data adjustments, which were open to criticism. 35 A recent comparison of TIV vaccines 36 with and without AS03 adjuvant (also squalene-based, like ADV) in elderly people indicated modestly greater relative efficacy (17%) of the adjuvanted vaccine vs. laboratory confirmed influenza A in one of two seasons studied. In the present study, intradermal vaccine (IDV) and TIV were alike in terms of seroprotection rates and GMTs to H1N1 and H3N2 antigens.…”
Section: Discussionmentioning
confidence: 99%
“…33 An observational study in elderly adults in Northern Italy 34 reported a lower rate of influenza-like illness or pneumonia after ADV relative to TIV but only after multiple data adjustments, which were open to criticism. 35 A recent comparison of TIV vaccines 36 with and without AS03 adjuvant (also squalene-based, like ADV) in elderly people indicated modestly greater relative efficacy (17%) of the adjuvanted vaccine vs. laboratory confirmed influenza A in one of two seasons studied. In the present study, intradermal vaccine (IDV) and TIV were alike in terms of seroprotection rates and GMTs to H1N1 and H3N2 antigens.…”
Section: Discussionmentioning
confidence: 99%
“…The observer-blinded randomized trial (ClinicalTrials.gov registration no. NCT00753272 [http://clinicaltrials.gov/show /NCT00753272]) was conducted at multiple sites in 15 countries in the Northern Hemisphere involving subjects who were Ն65 years old at trial entry (30). The trial was approved by the research ethics committees of all participating countries and conducted in accordance with the Declaration of Helsinki and good clinical practice guidelines.…”
Section: Methodsmentioning
confidence: 99%
“…The aim of this study was to explore the relationship between HA1 domain sequences and antigenicities (determined by HI) of influenza virus strains isolated from clinical breakthrough cases. These cases occurred during the follow up of a large international and multicenter clinical trial evaluating the relative efficacy of two trivalent influenza virus vaccines that was conducted over the 2008-2009 season in Ͼ43,000 adults Ն65 years old (30).…”
mentioning
confidence: 99%
“…There was no heterogeneity between the results of the studies (Q = 3.15, P = 0.98). Pooled estimate of the vaccine efficacy for the elderly was estimated at 19% (CI: 10-27) between 2 included studies [20,21] and there was no heterogeneity between the results of the studies (Q = 5.895, P = 0.552). The vaccine efficacy for the pregnant women was equal to 43% (CI: 29-56) [22].…”
Section: Vaccine Efficaciesmentioning
confidence: 99%