Merck, known as MSD outside of the US and Canada, announced positive results from the phase 3 STRIDE-13 trial evaluating Capvaxive® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Conference on Vaccines, in Lisbon, Portugal.
The trial evaluated the safety, tolerability and immunogenicity of CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged two to <18 years who have completed a primary paediatric 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, as measured by serotype-specific OPA GMTs at 30 days post-vaccination (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).
These results will be presented today (Abstract #00093) at the 6th Vaccines Conference organized by the ESCMID, in scientific collaboration with the European Society for Paediatric Infectious Diseases (ESPID), the European Association of Hospital Pharmacists (EAHP) and the European Medicines Agency (EMA).
Capvaxive is indicated in the US for:
• Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older
• Active immunisation for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
Capvaxive should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis).
Capvaxive is specifically designed for adults and helps provide coverage against the serotypes responsible for approximately 84% of IPD cases in adults 50 years of age and older, compared to approximately 52% covered by PCV20 (pneumococcal 20-valent conjugate vaccine), based on national-level CDC data from 2018-2022. In children and adolescents ages 2 to <18 years of age who are at increased risk of IPD, Capvaxive has the potential to provide additional protection by covering approximately 78% of IPD cases, with 11 unique serotypes that account for approximately 34% of IPD cases, based on national-level CDC data from 2019-2023 in individuals two–17 years old.
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