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A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age

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Trial Profile

A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age

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
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms STRIDE-4
  • Sponsors Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 26 Mar 2025 Results presented in a Merck & Co media release
    • 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.

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