Publication:
Prevention of influenza during mismatched seasons in older adults with an MF59-adjuvanted quadrivalent influenza vaccine: a randomised, controlled, multicentre, phase 3 efficacy study

dc.contributor.authorJiří Beranen_US
dc.contributor.authorHumberto Reynalesen_US
dc.contributor.authorAiri Poderen_US
dc.contributor.authorCharles Y. Yuen_US
dc.contributor.authorPunnee Pitisuttithumen_US
dc.contributor.authorLee Li Yuanen_US
dc.contributor.authorWim Vermeulenen_US
dc.contributor.authorCarole Verhoevenen_US
dc.contributor.authorBrett Leaven_US
dc.contributor.authorBin Zhangen_US
dc.contributor.authorDaphne Sawlwinen_US
dc.contributor.authorEsther Hamers-Heijnenen_US
dc.contributor.authorJonathan Edelmanen_US
dc.contributor.authorIgor Smolenoven_US
dc.contributor.otherDe La Salle Medical and Health Sciences Instituteen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherInstitut postgraduálního vzdělávání ve zdravotnictvíen_US
dc.contributor.otherSeqirus Australiaen_US
dc.contributor.otherClinical Research Centreen_US
dc.contributor.otherSeqirus USA Inc.en_US
dc.contributor.otherClinical Research Centeren_US
dc.contributor.otherSeqirus Inc.en_US
dc.contributor.otherSeqirus Netherlands B.V.en_US
dc.contributor.otherCentro de Atención e Investigación Médica (CAIMED)en_US
dc.date.accessioned2022-08-04T09:20:42Z
dc.date.available2022-08-04T09:20:42Z
dc.date.issued2021-07-01en_US
dc.description.abstractBackground: The absolute degree of protection from influenza vaccines in older adults has not been studied since 2001. This study aimed to show the clinical efficacy of an MF59-adjuvanted quadrivalent influenza vaccine (aQIV) in adults 65 years or older compared with adults not vaccinated to prevent influenza. Methods: We did a randomised, stratified, observer-blind, controlled, multicentre, phase 3 study at 89 sites in 12 countries in 2016–17 northern hemisphere and 2017 southern hemisphere influenza seasons. We enrolled community-dwelling male and female adults aged 65 years and older who were healthy or had comorbidities that increased their risk of influenza complications. We stratified eligible participants by age (cohorts 65–74 years and ≥75 years) and risk of influenza complications (high and low) and randomly assigned them (1:1) via an interactive response technology to receive either aQIV or a non-influenza comparator vaccine. We masked participants and outcome assessors to the administered vaccine. Personnel administering the vaccines did not participate in endpoint assessment. The primary outcome was absolute vaccine efficacy assessed by RT-PCR-confirmed influenza due to any influenza strain in the overall study population (full analysis set) from day 21 to 180 or the end of the influenza season. Vaccine efficacy was calculated on the basis of a Cox proportional hazard regression model for time to first occurrence of RT-PCR-confirmed influenza due to any strain of influenza. Safety outcomes were assessed in the overall study population. This trial was registered with ClinicalTrials.gov, NCT02587221. Findings: Northern hemisphere enrolment occurred between Sept 30, 2016, and Feb 28, 2017, and southern hemisphere enrolment between May 26, 2017, and 30 June 30, 2017. aQIV was administered to 3381 participants, who subsequently had 122 (3·6%) RT-PCR-confirmed influenza cases, and the comparator was administered to 3380 participants, who subsequently had 151 (4·5%) influenza cases. The majority, 214 (78·4%) of 273, were caused by influenza A H3N2. Most antigenically characterised isolates were mismatched to the vaccine strain (118 [85%] of 139). Vaccine efficacy was 19·8% (multiplicity-adjusted 95% CI −5·3 to 38·9) against all influenza and 49·9% (−24·0 to 79·8) against antigenically matched strains, when the protocol definition of influenza-like illness was used. The most common local solicited adverse event was injection site pain, reported by 102 (16·3%) of 624 participants in the aQIV group and 71 (11·2%) of 632 of participants in the comparator group. Deaths were evenly distributed; none were considered related to study vaccines. The safety profile for aQIV was similar to previously reported trials. Interpretation: The prespecified criterion for showing the efficacy of aQIV in older adults was not met during the influenza seasons with high amounts of vaccine strain mismatch. Vaccine efficacy was higher against influenza cases associated with higher fever, which represent more clinically significant disease. Funding: Seqirus UK.en_US
dc.identifier.citationThe Lancet Infectious Diseases. Vol.21, No.7 (2021), 1027-1037en_US
dc.identifier.doi10.1016/S1473-3099(20)30694-0en_US
dc.identifier.issn14744457en_US
dc.identifier.issn14733099en_US
dc.identifier.other2-s2.0-85101714766en_US
dc.identifier.urihttps://repository.li.mahidol.ac.th/handle/20.500.14594/78104
dc.rightsMahidol Universityen_US
dc.rights.holderSCOPUSen_US
dc.source.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85101714766&origin=inwarden_US
dc.subjectMedicineen_US
dc.titlePrevention of influenza during mismatched seasons in older adults with an MF59-adjuvanted quadrivalent influenza vaccine: a randomised, controlled, multicentre, phase 3 efficacy studyen_US
dc.typeArticleen_US
dspace.entity.typePublication
mu.datasource.scopushttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85101714766&origin=inwarden_US

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