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dc.contributor.authorAnnette Riden_US
dc.contributor.authorAbha Saxenaen_US
dc.contributor.authorAbdhullah H. Baquien_US
dc.contributor.authorAnant Bhanen_US
dc.contributor.authorJulie Binesen_US
dc.contributor.authorMarie Charlotte Bouesseauen_US
dc.contributor.authorArthur Caplanen_US
dc.contributor.authorJames Colgroveen_US
dc.contributor.authorAmes Dhaien_US
dc.contributor.authorRita Gomez-Diazen_US
dc.contributor.authorShane K. Greenen_US
dc.contributor.authorGagandeep Kangen_US
dc.contributor.authorRosanna Lagosen_US
dc.contributor.authorPatricia Lohen_US
dc.contributor.authorAlex John Londonen_US
dc.contributor.authorKim Mulhollanden_US
dc.contributor.authorPieter Neelsen_US
dc.contributor.authorPunee Pitisuttithumen_US
dc.contributor.authorSamba Cor Sarren_US
dc.contributor.authorMichael Selgeliden_US
dc.contributor.authorMark Sheehanen_US
dc.contributor.authorPeter G. Smithen_US
dc.contributor.otherKing's College Londonen_US
dc.contributor.otherOrganisation Mondiale de la Santeen_US
dc.contributor.otherJohns Hopkins Bloomberg School of Public Healthen_US
dc.contributor.otherUniversity of Torontoen_US
dc.contributor.otherUniversity of Melbourneen_US
dc.contributor.otherNYU School of Medicineen_US
dc.contributor.otherColumbia University Medical Centeren_US
dc.contributor.otherUniversity of the Witwatersrand, Faculty of Health Sciencesen_US
dc.contributor.otherInstituto Mexicano del Seguro Socialen_US
dc.contributor.otherSaint Michael's Hospital University of Torontoen_US
dc.contributor.otherChristian Medical College, Velloreen_US
dc.contributor.otherHospital de Ninos Robeto del Rioen_US
dc.contributor.otherMelbourne Law Schoolen_US
dc.contributor.otherCarnegie Mellon Universityen_US
dc.contributor.otherLondon School of Hygiene & Tropical Medicineen_US
dc.contributor.otherVaccine Advice BVBAen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherMinistry of Health and Social Action 1en_US
dc.contributor.otherMonash Universityen_US
dc.contributor.otherUniversity of Oxforden_US
dc.identifier.citationVaccine. Vol.32, No.37 (2014), 4708-4712en_US
dc.description.abstractVaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease. © 2014 The Authors.en_US
dc.rightsMahidol Universityen_US
dc.subjectBiochemistry, Genetics and Molecular Biologyen_US
dc.subjectImmunology and Microbiologyen_US
dc.titlePlacebo use in vaccine trials: Recommendations of a WHO expert panelen_US
Appears in Collections:Scopus 2011-2015

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