A Phase 3 trial (STRIDE-10) evaluated V116, a 21-valent pneumococcal conjugate vaccine, in adults over 50. The study compared V116 to a standard 23-valent pneumococcal vaccine (PPSV23) and assessed its immunogenicity, safety, and tolerability.
Key findings revealed that V116 induced strong immune responses to the serotypes responsible for the majority of invasive pneumococcal disease in adults. These results complement previous positive findings from other Phase 3 trials.
Despite the availability of pneumococcal conjugate vaccines for adults, there remain gaps in serotype coverage for invasive pneumococcal disease. V116’s design specifically targets the serotypes responsible for approximately 83% of adult invasive pneumococcal disease in individuals over 65.
Additional data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) suggests that V116 may help reduce the health and economic burden associated with pneumococcal disease in adults. Studies conducted in France, Sweden, Spain, and the Netherlands support this potential benefit.
V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA has granted V116 priority review, with a target action date of June 17, 2024. V116 aims to provide a new preventive option for adults against invasive pneumococcal disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
