Merck says Phase 2 trial of V114 in infants met primary endpoint

Merck announced results from a Phase 2 trial evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, as compared to the currently available 13-valent pneumococcal conjugate vaccine in healthy infants 6-12 weeks of age. In the study, designated V114-008, V114 met its primary endpoint by demonstrating noninferiority for the 13 serotypes contained in both vaccines. V114 also induced an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which are not contained in PCV13. In January 2019, V114 received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. The FDA’s decision was informed in part by immunogenicity data from this Phase 2 study, V114-008, and the Phase 1/2 V114-005 study in healthy adults and infants. Results of the V114-008 study were presented during an oral session at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases and reinforce continued progression of Phase 3 clinical studies with V114. V114-008, a double-blind, randomized, Phase 2 trial, compared the safety, tolerability, and immunogenicity of two different clinical lots of V114 to PCV13 in approximately 1,050 healthy infants at two, four, six and 12-15 months of age. In the study, the percentage of subjects who achieved the WHO-accepted threshold of immune response with either lot of V114 was noninferior to the percentage seen with PCV13 for the 13 serotypes shared between the two vaccines. For serotype 3, the percentage of subjects who achieved this threshold of immune response was higher for V114 compared with PCV13. For the two serotypes not included in PCV13, serotype 22F and serotype 33F, the percentage of subjects who achieved the defined threshold of immune response with V114 was above 98% and above 87%, respectively. Results were consistent between the two lots of V114 studied. Safety profiles were evaluated after each dose and throughout the study. In the study, the adverse event profile for V114, including the number of serious adverse events, was found to be comparable to PCV13. The percentage of subjects who reported clinical AEs and serious AEs was similar in all treatment arms. The most commonly reported adverse events were injection site reactions, the majority of which were mild to moderate in severity and of short duration.

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