Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data: A Secondary Cross-Protocol Analysis of 5 Randomized Clinical Trials

Andrews, L. I. B., Halloran, M. E., Neuzil, K. M., van der Laan, L., Huang, Y., Andriesen, J., Patel, M., Fisher, L. H., Janes, H., Rouphael, N., Walsh, S. R., Theodore, D. A., Tieu, H.-V., Sobieszczyk, M., El Sahly, H. M., Baden, L. R., Falsey, A. R., Campbell, T. B., Kelley, C. F., … Zorrilla, C. D. (2025). Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data. JAMA Network Open, 8(5), e2512763. https://doi.org/10.1001/jamanetworkopen.2025.12763
Authors:
Leah I B Andrews
M Elizabeth Halloran
Kathleen M Neuzil
Lars van der Laan
Yunda Huang
Jessica Andriesen
Mayur Patel
Leigh H Fisher
Holly Janes
Nadine Rouphael
Stephen R Walsh
Deborah A Theodore
Hong-Van Tieu
Magdalena Sobieszczyk
Hana M El Sahly
Lindsey R Baden
Ann R Falsey
Thomas B Campbell
Colleen F Kelley
Catherine Mary Healy
Lilly Immergluck
Benjamin Luft
Ian Hirsch
Guy de Bruyn
Carla Truyers
Frances Priddy
Kelsey M Sumner
Brendan Flannery
Dean Follmann
Peter B Gilbert
Affiliated Authors:
Deborah A Theodore
Hong-Van Tieu
Magdalena Sobieszczyk
Columbia Affiliation:
Subjects:
COVID-19 Vaccines (MeSH)
COVID-19 (MeSH)
Vaccine Efficacy (MeSH)
Randomized Controlled Trials as Topic (MeSH)
Research Design (MeSH)
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Publication Type:
Article
Unique ID:
10.1001/jamanetworkopen.2025.12763
PMID:
40434773
DOI:
10.1001/jamanetworkopen.2025.12763
Journal:
JAMA Network Open
Publication Date:
Data Source:
PubMed
Source Link:
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Record Created: