2012
DOI: 10.1016/j.vaccine.2012.08.005
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A prospective observational safety study on MF59® adjuvanted cell culture-derived vaccine, Celtura® during the A/H1N1 (2009) influenza pandemic

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Cited by 21 publications
(10 citation statements)
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“…In addition, this technology offers the potential to elicit an improved immune response through seed viruses that closely match the wild virus and also provides an option for people who are allergic to eggs [9]. Two cell-based H1pdm vaccines have been licensed and are currently used, Gelture and Optaflu [10]. Unfortunately, substitutions at residues 153–157 within HA often emerge upon passaging of the virus in cell cultures, and these substitutions are associated with reduced titers in hemagglutination inhibition (HAI) assays [11].…”
Section: Introductionmentioning
confidence: 99%
“…In addition, this technology offers the potential to elicit an improved immune response through seed viruses that closely match the wild virus and also provides an option for people who are allergic to eggs [9]. Two cell-based H1pdm vaccines have been licensed and are currently used, Gelture and Optaflu [10]. Unfortunately, substitutions at residues 153–157 within HA often emerge upon passaging of the virus in cell cultures, and these substitutions are associated with reduced titers in hemagglutination inhibition (HAI) assays [11].…”
Section: Introductionmentioning
confidence: 99%
“…121 Since the early 1990s, reports of more than 20 clinical studies involving greater than 20,000 subjects in over a dozen countries, as well as large-scale immunization programs have further confirmed the safety and immunogenicity of MDCK cell-derived influenza vaccines. As far as safety is concerned, overall AEs have been reported in up to 84% of the subjects, 112,114,116,117,[122][123][124][125] with a higher incidence in adults (60-84%) as compared to children (50-60%) and lowest (typically 15-25%, but sometimes up to 50%) in the elderly. 114,122,123,125 Total local AEs have ranged from 10% to 84%, 112,[114][115][116][117]122,124,126 again, typically higher in adults than in children, and lowest in the elderly.…”
Section: Mdck Cell-derived Influenza Vaccines: the Final Joust?mentioning
confidence: 99%
“…Mild to severe reactions requiring medical attention are observed at the most in 25% of the total local AEs, and are usually more frequent in children. 112,114,124 Systemic AEs to MDCK cell-derived influenza vaccines have been found to be lower as compared to local AEs. Total systemic AEs have ranged from 20% to 55%.…”
Section: Mdck Cell-derived Influenza Vaccines: the Final Joust?mentioning
confidence: 99%
“…Optaflu® (Novartis) and Flucelvax® (Novartis) were approved for individuals from the age of 18 years. Celtura® (Novartis) is a monovalent, cell culture-derived, inactivated subunit vaccine containing A(H1N1)pdm09 virus with the adjuvant MF59 [78]. Celtura® (Novartis) has been licensed in Europe.…”
Section: Recently Introduced Influenza Vaccinesmentioning
confidence: 99%