Merck: V1166 met key immunogenicity, safety endpoints in two Phase 3 trials

Merck announced topline results from two Phase 3 trials evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine in vaccine-naive and previously vaccinated individuals. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 in vaccine-naive adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study. In both studies, V116 had a safety profile comparable to the comparator in the studies. Results will be shared with the scientific community in the near future and will support global regulatory licensure applications. “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These results support the potential for V116 to become an important new preventative option for adults, regardless of prior pneumococcal vaccination status, by expanding coverage to include eight serotypes not currently included in any licensed vaccine. We are very grateful to the patients and investigators who contributed to these studies.”