A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults
Latest Information Update: 06 Apr 2025
At a glance
- Drugs V 116 (Primary) ; PCV 20
- Indications Pneumococcal infections
- Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
- Acronyms STRIDE-3
- 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.
- 01 Oct 2024 Results assessing the safety, tolerability, and immunogenicity of V116, were published in The Lancet Infectious Diseases.