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dc.contributor.authorSchwartz, L.M.
dc.contributor.authorHalloran, M.E.
dc.contributor.authorRowhani-Rahbar, A.
dc.date.accessioned2019-11-01T12:49:38Z
dc.date.available2019-11-01T12:49:38Z
dc.date.issued2017
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84999767800&doi=10.1016%2fj.vaccine.2016.10.077&partnerID=40&md5=1200c4ba0b085000ff345910bee17ceb
dc.identifier.urihttp://hdl.handle.net/10713/11327
dc.description.abstractBackground The test-negative design (TND), an epidemiologic method currently used to measure rotavirus vaccine (RV) effectiveness, compares the vaccination status of rotavirus-positive cases and rotavirus-negative controls meeting a pre-defined case definition for acute gastroenteritis. Despite the use of this study design in low-income settings, the TND has not been evaluated to measure rotavirus vaccine effectiveness. Methods This study builds upon prior methods to evaluate the use of the TND for influenza vaccine using a randomized controlled clinical trial database. Test-negative vaccine effectiveness (VE-TND) estimates were derived from three large randomized placebo-controlled trials (RCTs) of monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in sub-Saharan Africa and Asia. Derived VE-TND estimates were compared to the original RCT vaccine efficacy estimates (VE-RCTs). The core assumption of the TND (i.e., rotavirus vaccine has no effect on rotavirus-negative diarrhea) was also assessed. Results TND vaccine effectiveness estimates were nearly equivalent to original RCT vaccine efficacy estimates. Neither RV had a substantial effect on rotavirus-negative diarrhea. Conclusions This study supports the TND as an appropriate epidemiologic study design to measure rotavirus vaccine effectiveness in low-income settings. Copyright 2016 The Author(s)en_US
dc.description.sponsorshipThis publication is based on research funded in part by the Bill & Melinda Gates Foundation [ OPP1068644 ] and the National Institutes of Health [ NIH/NIAID MERIT R37 AI032042 ].en_US
dc.description.urihttps://doi.org/10.1016/j.vaccine.2016.10.077en_US
dc.language.isoen_USen_US
dc.publisherElsevier Ltden_US
dc.relation.ispartofVaccine
dc.subjectRotavirusen_US
dc.subjectTest-negative designen_US
dc.subjectVaccineen_US
dc.titleRotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative designen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.vaccine.2016.10.077
dc.identifier.pmid27876198


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