Pneumococcal 21-valent Conjugate Vaccine

(Capvaxive®)

Capvaxive®

Drug updated on 6/28/2024

Dosage FormInjection (intramuscular; 0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.
  • Indicated 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.

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Summary
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  • The Pneumococcal 21-valent Conjugate Vaccine (Capvaxive) is indicated for active immunization to prevent invasive disease and pneumonia caused by various Streptococcus pneumoniae serotypes in individuals aged 18 years and older.
  • The information provided was derived from a study, which was a randomized controlled trial comparing the safety and effectiveness of Capvaxive against PPSV23, another pneumococcal vaccine.
  • In terms of safety, no serious adverse events or deaths related to Capvaxive were reported. Common side effects included pain at the injection site as well as fatigue and myalgia; these were generally mild and short-lived.
  • In terms of effectiveness, Capvaxive met non-inferiority criteria when compared with PPSV23 for common serotypes and demonstrated superior protection against nine unique serotypes not covered by PPSV23.
  • Compared to other vaccines like PPSV23, Capvaxive showed similar safety but potentially broader protection against pneumococcal infections due to its coverage of additional serotypes.
  • The trials involved both younger adults (18–49 years) in Phase 1 and older adults (50+ years) in Phase 2. However, detailed outcomes based on age groups or other potential subgroups were not specified within the study reviewed.