Summary

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• Capvaxive (pneumococcal 21-valent conjugate vaccine) is indicated for active immunization for the prevention of invasive disease 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; and for active immunization 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.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• V116 demonstrated non-inferiority to PPSV23 for the 12 serotypes shared by both vaccines, with the added superiority of V116 over PPSV23 for the nine unique serotypes included in V116, assessed in a population aged 50 years or older and healthy adults aged 18-49 years.
• No significant differences in effectiveness among different population types or subgroups were reported in the provided evidence, indicating consistent immunogenicity outcomes across the studied populations.
• In Phase 1, injection site pain was reported by 73% (V116-1), 77% (V116-2), and 57% (PPSV23) of participants; systemic adverse events included fatigue in 27% (V116-1 and V116-2) and 17% (PPSV23), and myalgia in 27% (V116-1), 30% (V116-2), and 13% (PPSV23).
• In Phase 2, injection site pain was reported by 46% (V116) and 38% (PPSV23) of participants; systemic adverse events included fatigue in 19% (V116) and 12% (PPSV23). No vaccine-related serious adverse events or deaths were reported.
• There is no information available regarding population types or subgroups.