Search

Your search keyword '"Shahrul, Mt-Isa"' showing total 2 results
Start Over Author "Shahrul, Mt-Isa" Journal expert review of vaccines
2 results on '"Shahrul, Mt-Isa"'

1. 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

Author

Shahrul Mt-Isa, Justin R. Chumbley, Emma L. Crawford, Natalie Banniettis, Ulrike K. Buchwald, Jessica Weaver, and Thomas Weiss

Subjects
maic, indirect treatment comparison, pneumococcal conjugate vaccine, immunoglobulin g, immunogenicity, pcv15, gmc ratio, igg response rate, Internal medicine, RC31-1245
Abstract

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

Published
2023
Full Text
View/download PDF

2. Matching-adjusted indirect comparison of pneumococcal vaccines V114 and PCV20

Author

Thomas W. Weiss, Lauren A Abderhalden, Luwy Musey, and Shahrul Mt-Isa

Subjects
Adult, Serotype, medicine.medical_specialty, Matching (statistics), Pneumococcal disease, Immunology, Serogroup, Age and sex, complex mixtures, Pneumococcal Infections, Pneumococcal conjugate vaccine, Pneumococcal Vaccines, Indirect Treatment, Internal medicine, Drug Discovery, medicine, Humans, Pharmacology, Vaccines, Conjugate, business.industry, Middle Aged, Antibodies, Bacterial, Indirect comparison, Geometric mean titer, Molecular Medicine, business, medicine.drug
Abstract

Background V114 (15-valent pneumococcal conjugate vaccine [PCV15]) and a 20-valent PCV (PCV20) are approved for adults (≥18 years) in the United States. We present methodologies to indirectly compare immune responses to V114 versus PCV20. Research design and methods Indirect treatment comparison and matching-adjusted indirect comparison (MAIC) were performed to estimate opsonophagocytic activity (OPA) geometric mean titer (GMT) ratios of V114/PCV20 at 30 days post-vaccination with PCV13 as common comparator for 13 serotypes (STs) shared with a 13-valent PCV (PCV13) among pneumococcal vaccine-naive adults aged ≥60 years. Data from three V114 studies were pooled (V114, N = 2,196; PCV13, N = 843). In the MAIC analysis, data were reweighted, matching participant age and sex in NCT03760146 (PCV20, N = 1,507; PCV13, N = 1,490). Results The lower bound of V114/PCV20 OPA GMT ratio for all PCV13 STs is greater than the prespecified 0.5 non-inferiority margin and those for five PCV13 STs (3, 6A, 6B, 18C, and 23F) are greater than the prespecified 1.2 superiority margin. V114 was associated with 77% greater OPA GMT for ST3 versus PCV20. Conclusion V114 was non-inferior to PCV20 for all PCV13 STs and statistically superior for five PCV13 STs.

Published
2021
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results