Evidence map›Paper›PMID 38212836›Full record

Trial reportTrials2024

Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV).

Sarah Baos, Rachel Todd, Russell Thirard, Rosie Harris, Jana Kirwan, Katherine Joyce, David Hutton, Adam Finn, Madeleine Clout, Heike Cappel-Porter and 3 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Sarah BaosBristol Trials Centre, University of Bristol, Bristol, UK.
Rachel ToddBristol Trials Centre, University of Bristol, Bristol, UK. Rachel.todd@bristol.ac.uk.
Russell ThirardBristol Trials Centre, University of Bristol, Bristol, UK.
Rosie HarrisBristol Trials Centre, University of Bristol, Bristol, UK.
Jana KirwanBristol Trials Centre, University of Bristol, Bristol, UK.
Katherine JoyceBristol Trials Centre, University of Bristol, Bristol, UK.
David HuttonBristol Trials Centre, University of Bristol, Bristol, UK.
Adam FinnBristol Vaccine Centre, Schools of Population Health Sciences and of Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Madeleine CloutBristol Trials Centre, University of Bristol, Bristol, UK.
Heike Cappel-PorterBristol Trials Centre, University of Bristol, Bristol, UK.
Chris A RogersBristol Trials Centre, University of Bristol, Bristol, UK.
Rajeka LazarusUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Lucy CullifordBristol Trials Centre, University of Bristol, Bristol, UK.
University of Bristol · GBAt Bristol · GBUniversity Hospitals Bristol NHS Foundation Trust · GB

Funding

National Institute for Health Research Policy Research Programme NIHR203243National Institute for Health Research Policy Research Programme PR-R17-0916-22001
6 · The paper itself

Abstract

backgroundIn February 2021, the UK Department of Health and Social Care sought evidence on the safety and immunogenicity of COVID-19 and influenza vaccine co-administration to inform the 2021/2022 influenza vaccine policy. Co-administration could support vaccine uptake and reduce healthcare appointments. ComFluCOV was a randomised controlled trial designed to provide this evidence. This report outlines the methods used to deliver the trial in 6 months to answer an urgent public health question as part of the COVID-19 pandemic response.

methodsComFluCOV was commissioned by the Department of Health and Social Care and was managed by the Bristol Trials Centre, a UK-registered clinical trials unit. It was classed as an Urgent Public Health trial which facilitated fast-track regulatory approvals. Trial materials and databases were developed using in-house templates and those used in other COVID-19 vaccine trials. Participants were recruited by advertising, and via a trial website. Electronic trial systems enabled daily review of participant data. Weekly virtual meetings were held with stakeholders and trial sites.

resultsComFluCOV was delivered within 6 months from inception to reporting, and trial milestones to inform the Department of Health and Social Care policy were met. Set-up was achieved within 1 month. Regulators provided expedited reviews, with feedback ahead of submission. Recruitment took place at 12 sites. Over 380 site staff were trained. Overall, 679 participants were recruited in two months. The final report to the Department of Health and Social Care was submitted in September 2021, following a preliminary safety report in May 2021. Trial results have been published.

conclusionThe rapid delivery of ComFluCOV was resource intensive. It was made possible in part due to a unique set of circumstances created by the pandemic situation including measures put in place to support urgent public health research and public support for COVID-19 vaccine research. Elements of the trial could be adopted to increase efficiency in 'non-pandemic' situations including working with a clinical trials unit to enable immediate mobilisation of a team of experienced researchers, greater sharing of resources between clinical trials units, use of electronic trial systems and virtual meetings.

trial registrationISRCTN14391248, submitted on 17/03/2021. Registered on 30/03/2021.

Indexed as

COVID-19Influenza VaccinesCOVID-19 VaccinesHumansPandemicsSARS-CoV-2SeasonsUnited KingdomCOVID-19 VaccinesInfluenza VaccinesCOVID-19 vaccineEfficient deliveryInfluenza vaccineRandomised controlled trial (RCT)Urgent Public Health (UPH)

Identifiers

PMID38212836
PMCPMC10785514
OpenAlexW4390792907

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.