V116 is an investigational, 21-valent vaccine, currently in late-stage trial for prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population
Merck headquarters in Rahway, New Jersey, US. (Credit: Merck & Co., Inc., Rahway, NJ USA, and its affiliates.)
Merck said that its pneumococcal conjugate vaccine V116 was superior in immune response for 10 of 11 unique serotypes compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults aged 50 years and above in Phase 3 STRIDE-3 trial.
V116 is an investigational, 21-valent vaccine. It is currently in a late-stage trial for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population.
STRIDE-3 assessed the safety, immunogenicity and tolerability of V116 against PCV20 in adults who were not previously administered with a pneumococcal vaccine.
According to the results from the study, V116 demonstrated non-inferior immune responses against PCV20 for all 10 serotypes common to both vaccines at Day 30 in adults aged 50 years and above, which was cohort 1.
The immune responses elicited by V116 were superior for 10 of the 11 serotypes included in V116 but not in PCV20 at Day 30.
In addition, the proportions of patients with a greater than or equal to four-fold increase from Day 1 to Day 30.
At 30 days after immunisation, adults aged 18 to 49 years (Cohort 2) showed non-inferior immune responses compared to those aged 50 to 64 years.
Furthermore, the 21-valent vaccine demonstrated a safety profile like PCV20 throughout both groups.
Merck Research Laboratories global clinical development head and SVP Eliav Barr said: “These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.
“We are excited by the potential of V116 to impact public health through primary prevention through the use of a population-specific strategy that targets the serotypes responsible for the majority of invasive pneumococcal disease in adults.”
STRIDE-3 is a Phase 3, randomised, double-blind, active comparator-controlled trial.
The V116 late-stage clinical development programme consists of eight trials with the goal of assessing the safety, tolerability, and immunogenicity of V116 in diverse adult populations.
The American pharmaceutical company is providing data from STRIDE-3 to international regulatory bodies.