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@article{Lazarus:2021:10.1016/S0140-6736(21)02329-1,
author = {Lazarus, R and Baos, S and Cappel-Porter, H and Carson-Stevens, A and Clout, M and Culliford, L and Emmett, SR and Garstang, J and Gbadamoshi, L and Hallis, B and Harris, RA and Hutton, D and Jacobsen, N and Joyce, K and Kaminski, R and Libri, V and Middleditch, A and McCullagh, L and Moran, E and Phillipson, A and Price, E and Ryan, J and Thirard, R and Todd, R and Snape, MD and Tucker, D and Williams, RL and Nguyen-Van-Tam, JS and Finn, A and Rogers, CA and ComfluCOV, Trial Group},
doi = {10.1016/S0140-6736(21)02329-1},
journal = {Lancet},
pages = {2277--2287},
title = {Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial.},
url = {http://dx.doi.org/10.1016/S0140-6736(21)02329-1},
volume = {398},
year = {2021}
}

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TY  - JOUR
AB  - BACKGROUND: Concomitant administration of COVID-19 and influenza vaccines could reduce burden on health-care systems. We aimed to assess the safety of concomitant administration of ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine. METHODS: In this multicentre, randomised, controlled, phase 4 trial, adults in receipt of a single dose of ChAdOx1 or BNT162b2 were enrolled at 12 UK sites and randomly assigned (1:1) to receive concomitant administration of either an age-appropriate influenza vaccine or placebo alongside their second dose of COVID-19 vaccine. 3 weeks later the group who received placebo received the influenza vaccine, and vice versa. Participants were followed up for 6 weeks. The influenza vaccines were three seasonal, inactivated vaccines (trivalent, MF59C adjuvanted or a cellular or recombinant quadrivalent vaccine). Participants and investigators were masked to the allocation. The primary endpoint was one or more participant-reported solicited systemic reactions in the 7 days after first trial vaccination(s), with a difference of less than 25% considered non-inferior. Analyses were done on an intention-to-treat basis. Local and unsolicited systemic reactions and humoral responses were also assessed. The trial is registered with ISRCTN, ISRCTN14391248. FINDINGS: Between April 1 and June 26, 2021, 679 participants were recruited to one of six cohorts, as follows: 129 ChAdOx1 plus cellular quadrivalent influenza vaccine, 139 BNT162b2 plus cellular quadrivalent influenza vaccine, 146 ChAdOx1 plus MF59C adjuvanted, trivalent influenza vaccine, 79 BNT162b2 plus MF59C adjuvanted, trivalent influenza vaccine, 128 ChAdOx1 plus recombinant quadrivalent influenza vaccine, and 58 BNT162b2 plus recombinant quadrivalent influenza vaccine. 340 participants were assigned to concomitant administration of influenza and a second dose of COVID-19 vaccine at day 0 followed by placebo at day 21, and 339 participants were randomly assigned to concomitant adminis
AU  - Lazarus,R
AU  - Baos,S
AU  - Cappel-Porter,H
AU  - Carson-Stevens,A
AU  - Clout,M
AU  - Culliford,L
AU  - Emmett,SR
AU  - Garstang,J
AU  - Gbadamoshi,L
AU  - Hallis,B
AU  - Harris,RA
AU  - Hutton,D
AU  - Jacobsen,N
AU  - Joyce,K
AU  - Kaminski,R
AU  - Libri,V
AU  - Middleditch,A
AU  - McCullagh,L
AU  - Moran,E
AU  - Phillipson,A
AU  - Price,E
AU  - Ryan,J
AU  - Thirard,R
AU  - Todd,R
AU  - Snape,MD
AU  - Tucker,D
AU  - Williams,RL
AU  - Nguyen-Van-Tam,JS
AU  - Finn,A
AU  - Rogers,CA
AU  - ComfluCOV,Trial Group
DO  - 10.1016/S0140-6736(21)02329-1
EP  - 2287
PY  - 2021///
SP  - 2277
TI  - Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial.
T2  - Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(21)02329-1
UR  - https://www.ncbi.nlm.nih.gov/pubmed/34774197
VL  - 398
ER  -

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