Phase 3 trial to evaluate the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine 6 months later, in at-risk adults 18-49 years of age (PNEU-DAY): A subgroup analysis by baseline risk factors

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dc.contributor.authorHammitt, Laura L.
dc.contributor.authorQuinn, Dean
dc.contributor.authorJanczewska, Ewa
dc.contributor.authorPasquel, Francisco J.
dc.contributor.authorTytus, Richard
dc.contributor.authorReddy, K. Rajender
dc.contributor.authorAbarca, Katia
dc.contributor.authorKhaertynova, Ilsiyar M. M.
dc.contributor.authorDagan, Ron
dc.contributor.authorDawson, Rachel
dc.contributor.authorMcCauley, Jennifer
dc.contributor.authorShekar, Tulin
dc.contributor.authorFu, Wei
dc.contributor.authorPedley, Alison
dc.contributor.authorSterling, Tina
dc.contributor.authorTamms, Gretchen
dc.contributor.authorMusey, Luwy
dc.contributor.authorBuchwald, Ulrike K.
dc.date.accessioned2025-01-20T20:16:59Z
dc.date.available2025-01-20T20:16:59Z
dc.date.issued2023
dc.description.abstractImmunocompetent adults with certain medical and behavioral factors are at increased risk of pneumococcal disease. In some countries, sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults. This subgroup analysis from a phase 3 study evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults 18-49 years of age with pre-defined risk factors for pneumococcal disease. Safety and immunogenicity post-vaccination were analyzed by type and baseline number of risk factors for pneumococcal disease (1 and >= 2 risk factors). This analysis included 1,131 participants randomized 3:1 to receive either V114 or PCV13, followed by PPSV23. The majority (73.1%) of participants had at least one risk factor. Safety and tolerability profiles of V114 and PCV13 were similar across risk factor groups. V114 administered either alone or sequentially with PPSV23 6 months later was immunogenic for all 15 serotypes, including those not contained in PCV13, regardless of the number of baseline risk factors. V114 has the potential to broaden serotype coverage for at-risk adults.
dc.description.funderMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
dc.fuente.origenWOS
dc.identifier.doi10.1080/21645515.2023.2177066
dc.identifier.eissn2164-554X
dc.identifier.issn2164-5515
dc.identifier.urihttps://doi.org/10.1080/21645515.2023.2177066
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/92367
dc.identifier.wosidWOS:000943770900001
dc.issue.numero1
dc.language.isoen
dc.revistaHuman vaccines & immunotherapeutics
dc.rightsacceso restringido
dc.subjectPneumococcal vaccine
dc.subjectV114
dc.subject15-valent PCV
dc.subjectPCV13
dc.subjectPPSV23
dc.subjectat-risk adults
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titlePhase 3 trial to evaluate the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine 6 months later, in at-risk adults 18-49 years of age (PNEU-DAY): A subgroup analysis by baseline risk factors
dc.typeartículo
dc.volumen19
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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