Pneumococcal serotypes missing prespecified efficacy threshold in immunogenicity trials: real-world evidence from national immunization programs

Autor: Johnna Perdrizet, Michele Wilson, Warisa Wannaadisai, Kevin Apodaca, Lindsay Grant
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Expert Review of Vaccines, Vol 23, Iss 1, Pp 879-886 (2024)
Druh dokumentu: article
ISSN: 14760584
1744-8395
1476-0584
DOI: 10.1080/14760584.2024.2409662
Popis: Objectives The 13-valent (PCV13) and 10-valent (PCV10) pneumococcal conjugate vaccines missed non-inferiority for certain 7-valent (PCV7) serotypes in immunogenicity trials. This study examines the population-level IPD case trends for these serotypes.Methods We identified six countries with national IPD surveillance data that introduced PCV13 (Canada, Germany, Israel, Italy, South Africa, and the United States) and three with PCV10 (Finland, Brazil, and the Netherlands). We extracted country-specific annual IPD case counts for PCV7 serotypes that missed non-inferiority and met non-inferiority (6B + 23F and PCV7 minus [6B + 23F] serotypes for PCV10 countries; 6B +9V + 23F, and PCV7 minus [6B +9V + 23F] serotypes for PCV13 countries) in clinical trials. Case count data for each country were plotted for observed serotype trends in different age groups (
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