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A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

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Trial Profile

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Apr 2025

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At a glance

  • Drugs V 116 (Primary) ; Pneumococcal vaccine; V 114
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms STRIDE-6
  • Sponsors Merck Sharp & Dohme

    • Most Recent Events

    • 26 Mar 2025 According to a Merck & Co media release, based on safety and immunogenicity data from the Phase 3 STRIDE clinical program, European Commission (EC) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in individuals 18 years of age and older.
    • 31 Jan 2025 According to a Merck & Co media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older and a final decision is expected by the second quarter of 2025.
    • 16 Jul 2024 According to a Merck & Co media release, company announced that Health Canada has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for Active immunization for the prevention of invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes (3, 6A, 6C, 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 and older.

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