An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants
| Autor: | Shahrul Mt-Isa, Justin R. Chumbley, Emma L. Crawford, Natalie Banniettis, Ulrike K. Buchwald, Jessica Weaver, Thomas Weiss |
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| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Expert Review of Vaccines, Vol 22, Iss 1, Pp 906-917 (2023) |
| Druh dokumentu: | article |
| ISSN: | 1476-0584 1744-8395 14760584 |
| DOI: | 10.1080/14760584.2023.2270039 |
| Popis: | Objectives Immunogenicity between 15-valent V114 (PCV15) and 20-valent PCV20 pneumococcal conjugate vaccines in healthy infants is compared in an indirect treatment comparison and matching-adjusted indirect comparison. Hypotheses: immunogenicity of V114 is non-inferior to PCV20 for all PCV13 serotypes, and superior to PCV20 for serotype 3 based on lower bound margins. Methods Two phase 3 pivotal studies on 3 + 1 pediatric vaccination schedule at age 2, 4, 6, and 12–15 months compared V114 (N = 858) to PCV13 (N = 856) and PCV20 (N = 1001) to PCV13 (N = 987). Infant’s age and race in V114 study were matched to those in PCV20 study. Primary endpoints were serotype-specific Immunoglobulin G (IgG) response rate difference (RRD) 30 days post-dose (PD)3; IgG geometric mean concentration (GMC) ratios 30 days PD3 and PD4. Results V114 was non-inferior (${\rm{margi}}{{\rm{n}}_{RRD}}$>-10%-point; ${\rm{margi}}{{\rm{n}}_{GMCratio}}$ >0.5) to PCV20 (p-value 0%-point; ${\rm{margi}}{{\rm{n}}_{GMCratio}}$ >1.2) to PCV20 (p-value |
| Databáze: | Directory of Open Access Journals |
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