Merck & Co Inc MRK released results from the STRIDE-3 Phase 3 trial evaluating V116, the company's investigational 21-valent pneumococcal conjugate vaccine.
The trial evaluated the immunogenicity, tolerability, and safety of V116 compared to Pfizer Inc's PFE Prevnar 20 (PCV20) in adults who had not previously received a pneumococcal vaccine.
In adults 50 years of age and older (Cohort 1), V116 elicited non-inferior immune responses compared to PCV20 for all 10 serotypes common to both vaccines as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30.
In adults 18 to 49 (Cohort 2), V116 elicited non-inferior immune responses (immunobridged) compared to adults 50 to 64, as assessed by serotype-specific OPA GMTs 30 days post-vaccination.
Across both cohorts, V116 had a safety profile comparable to PCV20.
The V116 Phase 3 clinical development program comprises eight trials (n=8,830) investigating the safety, tolerability, and immunogenicity of V116 in various adult populations.
V116 utilizes the CRM197 vaccine carrier protein, produced using Ligand Pharmaceuticals Incorporated LGND patent-protected Pelican Expression Technology platform. If approved, Ligand is entitled to a royalty on worldwide net sales.
In July, Merck announced topline results from two Phase 3 trials evaluating V116 in vaccine-naïve and previously vaccinated individuals.
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