Novel Drugs & Emergent Therapeutics | Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years
Published on MedED: 3 July 2023
Published in Souce journal: 23 Aug 2022
Type of article: Summary of Novel Drug Research
MedED Catalogue Reference: MIND002
Category Tabs: Vaccines | Infectious Diseases| Pneumococcal Conjugate Vaccine | Phase 3 study
Sources: Clinical Infectious Diseases
Published in Souce journal: 23 Aug 2022
Type of article: Summary of Novel Drug Research
MedED Catalogue Reference: MIND002
Category Tabs: Vaccines | Infectious Diseases| Pneumococcal Conjugate Vaccine | Phase 3 study
Sources: Clinical Infectious Diseases
This phase 3 study evaluated the safety, tolerability, and immunogenicity of a 20-valent pneumococcal conjugate vaccine (PCV20).
Thier findings are broadly summarised as:
- Safety assessments showed similar local reactions and adverse events between PCV20 and PCV13, with no identified safety concerns.
- The primary immunogenicity objectives were met, as PCV20 demonstrated non-inferior immune responses compared to PCV13 for the matched serotypes and to PPSV23 for additional serotypes in participants aged 60 years and older.
- Robust immune responses to all 20 vaccine serotypes were observed across age groups.
The researches concluded that PCV20 was safe, well-tolerated, and had immunogenicity comparable to PCV13 and PPSV23. PCV20 is expected to enhance protection against pneumococcal disease in adults.
The clinical trial registration number for this study is NCT03760146.
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