The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England.
Journal
NPJ vaccines
ISSN: 2059-0105
Titre abrégé: NPJ Vaccines
Pays: England
ID NLM: 101699863
Informations de publication
Date de publication:
23 Feb 2022
23 Feb 2022
Historique:
received:
09
07
2021
accepted:
20
01
2022
entrez:
24
2
2022
pubmed:
25
2
2022
medline:
25
2
2022
Statut:
epublish
Résumé
We estimated the frequency of non-specific influenza-associated clinical endpoints to inform the feasibility of pragmatic randomized controlled trials (RCT) assessing relative vaccine effectiveness (rVE). Hospitalization rates of respiratory, cardiovascular and diabetic events were estimated from Denmark and England's electronic databases and stratified by age, comorbidity and influenza vaccination status. We included a seasonal average of 4.5 million Danish and 7.2 million English individuals, 17 and 32% with comorbidities. Annually, approximately 1% of Danish and 0.5% of English individuals were hospitalized for selected events, ~50% of them respiratory. Hospitalization rates were 40-50-fold and 2-10-fold higher in those >50 years and with comorbidities, respectively. Our findings suggest that a pragmatic RCT using non-specific endpoints is feasible. However, for outcomes with rates <2.5%, it would require randomization of ~100,000 participants to have the power to detect a rVE difference of ~13%. Targeting selected groups (older adults, those with comorbidities) where frequency of events is high would improve trial efficiency.
Identifiants
pubmed: 35197469
doi: 10.1038/s41541-022-00444-6
pii: 10.1038/s41541-022-00444-6
pmc: PMC8866398
doi:
Types de publication
Journal Article
Langues
eng
Pagination
25Informations de copyright
© 2022. The Author(s).
Références
N Engl J Med. 2017 Jun 22;376(25):2427-2436
pubmed: 28636855
BMC Infect Dis. 2015 Oct 17;15:429
pubmed: 26474974
Lancet Respir Med. 2017 Sep;5(9):738-746
pubmed: 28736045
Vaccine. 2015 Sep 11;33(38):4988-93
pubmed: 26212007
BMJ. 2019 Nov 27;367:l6326
pubmed: 31776110
Int J Epidemiol. 2006 Apr;35(2):337-44
pubmed: 16368725
Lancet Infect Dis. 2012 Jan;12(1):36-44
pubmed: 22032844
JAMA. 2004 Sep 15;292(11):1333-40
pubmed: 15367555
Am J Epidemiol. 2018 Feb 1;187(2):378-388
pubmed: 28679157
Lancet Infect Dis. 2021 Jul;21(7):1027-1037
pubmed: 33577767
Vaccine. 2019 Mar 7;37(11):1484-1490
pubmed: 30745146
N Engl J Med. 2014 Aug 14;371(7):635-45
pubmed: 25119609
Am J Public Health. 2005;95 Suppl 1:S144-50
pubmed: 16030331
J Infect Dis. 2020 Jan 2;221(2):183-190
pubmed: 31678990
Emerg Med J. 2003 Mar;20(2):164-8
pubmed: 12642531
N Engl J Med. 2020 Feb 13;382(7):674-678
pubmed: 32053307
N Engl J Med. 2018 Jan 25;378(4):345-353
pubmed: 29365305
Eur J Epidemiol. 2019 Jan;34(1):91-99
pubmed: 30219957
NPJ Vaccines. 2021 Feb 16;6(1):25
pubmed: 33594050
Int J Epidemiol. 2015 Jun;44(3):827-36
pubmed: 26050254
Am Heart J. 2021 Jul;237:54-61
pubmed: 33722585
Influenza Other Respir Viruses. 2018 Jan;12(1):22-29
pubmed: 29197154
Influenza Other Respir Viruses. 2017 Sep;11(5):372-393
pubmed: 28745014
JAMA. 2013 Oct 23;310(16):1711-20
pubmed: 24150467
Clin Infect Dis. 2021 Dec 6;73(11):e4251-e4259
pubmed: 33211809
Vaccine. 2021 Mar 15;39 Suppl 1:A51-A55
pubmed: 32576459
Am J Epidemiol. 1985 Feb;121(2):309-23
pubmed: 3839345
PLoS One. 2021 Jan 7;16(1):e0244746
pubmed: 33411792
Eur J Epidemiol. 2014 Aug;29(8):541-9
pubmed: 24965263
Clin Epidemiol. 2015 Nov 17;7:449-90
pubmed: 26604824
Cochrane Database Syst Rev. 2015 May 05;(5):CD005050
pubmed: 25940444
Am Heart J. 2017 Jul;189:94-102
pubmed: 28625387
JAMA. 2021 Jan 5;325(1):39-49
pubmed: 33275134
Circulation. 2019 Jan 29;139(5):575-586
pubmed: 30586760
Int J Epidemiol. 2017 Aug 1;46(4):1093-1093i
pubmed: 28338941
Eur Respir J. 2018 Mar 29;51(3):
pubmed: 29563170
Int J Epidemiol. 2019 Dec 1;48(6):1740-1740g
pubmed: 30859197
Stat Methods Med Res. 2017 Aug;26(4):1802-1823
pubmed: 26031359