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dc.contributor.authorPatel, Priyanka D
dc.contributor.authorPatel, Pratiksha
dc.contributor.authorLiang, Yuanyuan
dc.contributor.authorMeiring, James E
dc.contributor.authorMisiri, Theresa
dc.contributor.authorMwakiseghile, Felistas
dc.contributor.authorTracy, J Kathleen
dc.contributor.authorMasesa, Clemens
dc.contributor.authorMsuku, Harrison
dc.contributor.authorBanda, David
dc.contributor.authorMbewe, Maurice
dc.contributor.authorHenrion, Marc
dc.contributor.authorAdetunji, Fiyinfolu
dc.contributor.authorSimiyu, Kenneth
dc.contributor.authorRotrosen, Elizabeth
dc.contributor.authorBirkhold, Megan
dc.contributor.authorNampota, Nginache
dc.contributor.authorNyirenda, Osward M
dc.contributor.authorKotloff, Karen
dc.contributor.authorGmeiner, Markus
dc.contributor.authorDube, Queen
dc.contributor.authorKawalazira, Gift
dc.contributor.authorLaurens, Matthew B
dc.contributor.authorHeyderman, Robert S
dc.contributor.authorGordon, Melita A
dc.contributor.authorNeuzil, Kathleen M
dc.date.accessioned2021-09-21T11:43:17Z
dc.date.available2021-09-21T11:43:17Z
dc.date.issued2021-09-16
dc.identifier.urihttp://hdl.handle.net/10713/16681
dc.description.abstractBackground: Typhoid fever caused by multidrug-resistant H58 Salmonella Typhi is an increasing public health threat in sub-Saharan Africa. Methods: We conducted a phase 3, double-blind trial in Blantyre, Malawi, to assess the efficacy of Vi polysaccharide typhoid conjugate vaccine (Vi-TCV). We randomly assigned children who were between 9 months and 12 years of age, in a 1:1 ratio, to receive a single dose of Vi-TCV or meningococcal capsular group A conjugate (MenA) vaccine. The primary outcome was typhoid fever confirmed by blood culture. We report vaccine efficacy and safety outcomes after 18 to 24 months of follow-up. Results: The intention-to-treat analysis included 28,130 children, of whom 14,069 were assigned to receive Vi-TCV and 14,061 were assigned to receive the MenA vaccine. Blood culture-confirmed typhoid fever occurred in 12 children in the Vi-TCV group (46.9 cases per 100,000 person-years) and in 62 children in the MenA group (243.2 cases per 100,000 person-years). Overall, the efficacy of Vi-TCV was 80.7% (95% confidence interval [CI], 64.2 to 89.6) in the intention-to-treat analysis and 83.7% (95% CI, 68.1 to 91.6) in the per-protocol analysis. In total, 130 serious adverse events occurred in the first 6 months after vaccination (52 in the Vi-TCV group and 78 in the MenA group), including 6 deaths (all in the MenA group). No serious adverse events were considered by the investigators to be related to vaccination. Conclusions: Among Malawian children 9 months to 12 years of age, administration of Vi-TCV resulted in a lower incidence of blood culture-confirmed typhoid fever than the MenA vaccine. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT03299426.).en_US
dc.description.urihttps://doi.org/10.1056/NEJMoa2035916en_US
dc.description.urihttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202713/en_US
dc.language.isoenen_US
dc.publisherMassachusetts Medical Societyen_US
dc.relation.ispartofThe New England Journal of Medicineen_US
dc.rightsCopyright © 2021 Massachusetts Medical Society.en_US
dc.subject.lcshChildrenen_US
dc.subject.meshTyphoid-Paratyphoid Vaccinesen_US
dc.subject.meshMalawien_US
dc.titleSafety and Efficacy of a Typhoid Conjugate Vaccine in Malawian Childrenen_US
dc.typeArticleen_US
dc.identifier.doi10.1056/NEJMoa2035916
dc.identifier.pmid34525285
dc.source.volume385
dc.source.issue12
dc.source.beginpage1104
dc.source.endpage1115
dc.source.countryUnited Kingdom
dc.source.countryUnited States
dc.source.countryUnited States


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