Merck & Co. Inc. (NYSE:MRK) on Thursday released results from the Phase 3 STRIDE-13 trial evaluating Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Conference.
The trial evaluated the safety, tolerability, and immunogenicity of Capvaxive compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 to <18 years who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease.
Key findings from the STRIDE-13 study include:
Capvaxive elicited immune responses to all 21 serotypes (or strains) as assessed by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days post-vaccination (secondary immunogenicity endpoint).
Capvaxive was noninferior to PPSV23 for each of the 12 serotypes shared between the vaccines and superior to PPSV23 for each of the nine serotypes unique to Capvaxive (primary immunogenicity endpoint).
The proportions of participants with adverse events (AEs), including systemic and serious vaccine-related AEs, were generally comparable between groups (primary safety endpoint).
In June 2024, the FDA approved Merck’s Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to protect against 21 strains of bacteria to prevent a severe form of pneumococcal disease.
It's the first pneumococcal conjugate vaccine specifically designed to protect adults from a bacterium known as pneumococcus that can cause serious illnesses and a lung infection.
In March, Vaxcyte Inc. (NASDAQ:PCVX) released topline results from its Phase 2 dose-finding study evaluating the safety, tolerability and immunogenicity of VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), compared to Pfizer Inc.'s (NYSE:PFE) Prevnar 20 (PCV20) in healthy infants.
The company selected the VAX-24 Mid-dose as the basis for advancing an optimized dose formulation to a potential Phase 3 program.
Pending the VAX-31 infant Phase 2 study, the topline data are anticipated in mid-2026, and it plans to initiate an infant Phase 3 study with either VAX-24 or VAX-31.
Price Action: MRK stock is up 0.23% at $84.22 during the premarket session at the last check on Thursday.
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