Merck (MSD) has reported positive results from two Phase III clinical trials of its investigational 15-valent pneumococcal conjugate vaccine, V114.
V114 is an investigational 15-valent pneumococcal conjugate vaccine being developed to prevent pneumococcal disease in adults and children. The vaccine comprises pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein.
It includes 22F and 33F serotypes that are commonly related to invasive pneumococcal disease and not included in the pneumococcal conjugate vaccine currently licensed for adults.
The Phase III studies assess the safety, tolerability and immunogenicity of V114, and the vaccine candidate is said to have reached safety and immunogenicity objectives.
Data from the PNEU-WAY (V114-018) trial revealed that V114 induce an immune response to all 15 serotypes included in the vaccine, in adults aged 18 years or above with human immunodeficiency virus (HIV).
Meanwhile, the PNEU-FLU (V114-021) study results from healthy participants aged 50 years or older showed that V114 can be administered concomitantly with the quadrivalent influenza vaccine.
Merck Research Laboratories vaccine clinical research executive director in biologics Dr Luwy Musey said: “Results from these first two Phase III studies of V114 are encouraging and we look forward to sharing additional data in the future from our ongoing clinical development programme, including our pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.”
The Phase III clinical development programme for V114 involves 16 studies assessing its safety, tolerability and immunogenicity in populations at increased risk for pneumococcal disease.
Merck plans to work with the US Food and Drug Administration (FDA) and other regulators to potentially file for licensure of the vaccine.
In May last year, the company reported positive results from the Phase II trial of V114.