000			03604nam a2200349 4500
001			ESSALUD
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040			_aBMG
041			_aeng
100			_aLeroux-Roels, Isabel _eAutor _954553
245			_aEfficacy and safety of an mRNA seasonal influenza vaccine in adults
300			_apáginas: 1803-1813
520			_aBackground: Seasonal influenza causes substantial illness and death in adults 50 years of age or older, even with current vaccines. An investigational messenger RNA (mRNA)–based vaccine called mRNA-1010 encodes hemagglutinin glycoproteins from World Health Organization–recommended influenza strains. Methods: In this phase 3, double-blind, active-controlled trial, we randomly assigned adults 50 years of age or older to receive trivalent mRNA-1010 (37.5 μg, which includes 12.5 μg of each strain) or a licensed standard-dose comparator. The primary efficacy end point was relative vaccine efficacy against reverse-transcriptase–polymerase-chain-reaction (RT-PCR)–confirmed, protocol-defined influenza-like illness caused by influenza A or B, from at least 14 days after vaccination through the end of the influenza season. Hypothesis testing was conducted hierarchically to assess noninferiority (lower boundary of the 95% confidence interval [CI], >−10%), superiority (lower boundary of the 95% CI, >0%), and a higher level of superiority (lower boundary of the 95% CI, >9.1%). Results: A total of 40,703 participants received mRNA-1010 (20,350 participants) or the standard-dose comparator (20,353 participants); the median follow-up was 181 days (range, 1 to 227). RT-PCR–confirmed, protocol-defined influenza-like illness was observed in 411 of 20,179 recipients of mRNA-1010 (2.0%) and 557 of 20,124 recipients of the standard-dose comparator (2.8%), which corresponds to a relative vaccine efficacy of 26.6% (95% CI, 16.7 to 35.4), thereby meeting the criteria for noninferiority, superiority, and higher-level superiority. Solicited adverse reactions were more frequent with mRNA-1010 than with the standard-dose comparator (injection-site pain in 65.8% vs. 29.8%, fatigue in 45.1% vs. 20.3%, headache in 37.8% vs. 18.0%, and myalgia in 35.4% vs. 11.6%); most reactions were mild to moderate and transient. Serious adverse events were reported in 2.2% of the recipients of mRNA-1010 (with three events considered by the investigator to be vaccine-related) and in 1.9% of the recipients of the standard-dose comparator (with two events considered by the investigator to be vaccine-related). Conclusions: In this trial, mRNA-1010 was superior to standard-dose licensed vaccines for prevention of RT-PCR–confirmed, protocol-defined influenza-like illness in adults 50 years of age or older. Solicited adverse reactions were more frequent with mRNA-1010.
650			_aGERIATRÍA _91852
650			_aENVEJECIMIENTO GENERAL _954554
650			_aMEDICINA CLÍNICA HOSPITALARIA _953754
650			_aENFERMEDADES INFECCIOSAS GENERALES _954087
650			_aINFLUENZA _954088
650			_aINFECCIONES VIRALES _953766
650			_aTERAPIAS DE ARN _954555
650			_aVACUNAS _98158
700			_aHuang, Grace _954556
700			_aFerguson, Murdo _954557
700			_aKohli, Anita _954558
700			_aClark, Rebecca _954559
700			_aBickel, Markus _954560
700			_aSoens, Mieke _954561
773	0		_022717 _922676 _dMassachusetts NEJM Group _oNEJM015 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-08-31 _zsqb
999			_c22927 _d22927