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dc.contributor.authorPavlinac, Patricia B
dc.contributor.authorRogawski McQuade, Elizabeth T
dc.contributor.authorPlatts-Mills, James A
dc.contributor.authorKotloff, Karen L
dc.contributor.authorDeal, Carolyn
dc.contributor.authorGiersing, Birgitte K
dc.contributor.authorIsbrucker, Richard A
dc.contributor.authorKang, Gagandeep
dc.contributor.authorMa, Lyou-Fu
dc.contributor.authorMacLennan, Calman A
dc.contributor.authorPatriarca, Peter
dc.contributor.authorSteele, Duncan
dc.contributor.authorVannice, Kirsten S
dc.date.accessioned2022-04-26T12:54:14Z
dc.date.available2022-04-26T12:54:14Z
dc.date.issued2022-03-22
dc.identifier.urihttp://hdl.handle.net/10713/18661
dc.description.abstractVaccine candidates for Shigella are approaching phase 3 clinical trials in the target population of young children living in low- and middle-income countries. Key study design decisions will need to be made to maximize the success of such trials and minimize the time to licensure and implementation. We convened an ad hoc working group to identify the key aspects of trial design that would meet the regulatory requirements to achieve the desired indication of prevention of moderate or severe shigellosis due to strains included in the vaccine. The proposed primary endpoint of pivotal Shigella vaccine trials is the efficacy of the vaccine against the first episode of acute moderate or severe diarrhea caused by the Shigella strains contained within the vaccine. Moderate or severe shigellosis could be defined by a modified Vesikari score with dysentery and molecular detection of vaccine-preventable Shigella strains. This report summarizes the rationale and current data behind these considerations, which will evolve as new data become available and after further review and consultation by global regulators and policymakers.en_US
dc.description.urihttps://doi.org/10.3390/vaccines10040489en_US
dc.language.isoenen_US
dc.publisherMDPI AGen_US
dc.relation.ispartofVaccinesen_US
dc.subjectShigellaen_US
dc.subjectlow and middle-income countriesen_US
dc.subjectpediatricsen_US
dc.subjectvaccine trial designen_US
dc.titlePivotal Shigella Vaccine Efficacy Trials-Study Design Considerations from a Vaccine Trial Design Working Group.en_US
dc.typeArticleen_US
dc.identifier.doi10.3390/vaccines10040489
dc.identifier.pmid35455238
dc.source.journaltitleVaccines
dc.source.volume10
dc.source.issue4
dc.source.countrySwitzerland


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