Immunogenicity and reactogenicity of fractional vs. full booster doses of COVID-19 vaccines: a non-inferiority, randomised, double-blind, phase IV clinical trial in Brazil
Puga M, de Oliveira R, da Silva P, Charu V, Hedlin H, Lu D, Zhang A, Shaw B, Rosser J, Seidman J, Carter A, Qamar F, Luby S, Garrett D, Croda J. Immunogenicity and reactogenicity of fractional vs. full booster doses of COVID-19 vaccines: a non-inferiority, randomised, double-blind, phase IV clinical trial in Brazil. The Lancet Regional Health - Americas 2025, 44: 101031. PMID: 40083966, PMCID: PMC11904515, DOI: 10.1016/j.lana.2025.101031.Peer-Reviewed Original ResearchDose of BNT162b2Fractionated dosesNon-inferiorityNon-inferiority thresholdSeroresponse ratesDouble-blindBooster vaccinationAdverse eventsSystemic adverse eventsPhase IV clinical trialBaseline antibody levelsIV clinical trialDose of COVID-19 vaccineDose of vaccineNon-inferiority studyReduced side effectsAdministering booster vaccinationResource-limited settingsBinding IgG antibodiesImmunocompetent adultsStudy vaccineDose boosterTreatment armsParallel-groupBooster dose
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