Merck declares positive results from trial of pneumonia vaccine

German pharmaceutical company Merck KGaA (Merck) has reported positive results from its Phase III STRIDE-10 trial of V116, a pneumococcal conjugate vaccine aimed at preventing invasive pneumococcal disease and pneumonia in adults. The 21-valent V116 vaccine is being developed for this purpose. In the study, which was randomized and double-blind, V116 demonstrated comparable immunogenicity, safety, and tolerability to the established 23-valent pneumococcal vaccine (PPSV23). Adults aged 50 years and older, who had not previously been vaccinated against pneumococcal disease, were enrolled and received a single dose of either PPSV23 or V116. V116 showed noninferior immune responses for the 12 common serotypes and superior immune responses for the nine unique serotypes it targets, while maintaining a safety profile similar to that of PPSV23. Merck anticipates that V116 could significantly decrease the economic and health impacts of pneumococcal disease across Europe. The vaccine is currently under review by the US FDA and the EMA, with a priority review status granted by the FDA and a target action date set for June 17.