Document is current

Article History

Accepted: 20 June 2021

First Online: 22 July 2021

Declarations

:

: The ALIC⁴E trial and the contributions of AWV, EB, SC, NF, PS, NJH, PaB, AGS, DG, KK, RMP, RRJ, BS, NT, RA, CCB and PB were funded by the European Commission’s Seventh Framework Programme: Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) (grant HEALTH-F3-2013-602525). PB, XL, JB and RB acknowledge partial Methusalem funding from the VAX-IDEA and ASCID Centres of Excellence in vaccination and infectious diseases at the University of Antwerp. JB and RB were funded by their personal postdoctoral grants from the Research Foundation—Flanders (FWO). PS acknowledges that The Healthcare Committee, Region Västra Götaland, Sweden, partially funded the Swedish part of the study.

: NF reports grants from Synairgen outside the submitted work. CCB reports grants from National Institute for Health Research Health and grants from National Institute for Health Research Health Protection Research Unit on Health Care Associated Infections and Antimicrobial Resistance during the conduct of the study; personal fees from Roche Molecular Systems, grants from Roche Molecular Diagnostics, personal fees from Pfizer, personal fees from Roche diagnostics, personal fees from Janssen Pharmaceuticals, outside the submitted work. DG reports being employed since 1 June 2020 by Roche Pharma (Schweiz) AG, Basel, Switzerland. Data collections for this articlet were completed before his current employment. The current employment did not influence this article. PB reports grants from European commission IMI, outside the submitted work. XL, JB, AWV, EB, RB, SC, PS, NJH, PaB, AGS, KK, RMP, RRJ, BS, NT and RA report no conflicts of interest.

: The study was approved by the National Research Ethics Service Committee South Central—Oxford B. Clinical trial authority approval was obtained from the UK Medicines and Healthcare products Regulatory Agency. Per participating country appropriate institutional, national research ethics committee and regulatory approvals were obtained. The ALIC⁴E trial was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

: All trial participants provided written informed consent.

: Not applicable.

: Almost all the data analysed and generated during this study are included in this published article and its supplementary information files. Formal requests for additional data can be made to the corresponding author (XL) or the senior authors (AWV, PB) using a bespoke data request form delineating research aims, methods and the variables.

: Not applicable.

: All authors made substantial contributions to the design of the work and interpretation of data. CCB was the chief investigator of this trial. CCB, AWV and EB led the development of the clinical trial, and managed and coordinated the trial. PB, XL and JB designed the unit cost collection templates. PS, NH, SC, NF, PaB, AGS, DG, KK, RMP, RRJ, BS, NT, RA and AWV were responsible for their network’s participation in the trial, and collected or reviewed the country-specific unit costs. XL performed the literature searches, data collection and data analyses. XL and JB wrote the initial draft. PB, RB, CCB and AWV contributed to the analyses and substantively revised the manuscript. All authors critically reviewed and commented on previous versions of the manuscript. All authors have read and approved the submitted version and agreed  to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.