Drug updated on 10/17/2024
| Dosage Form | Injection (intramuscular; 0.5 mL) |
| Drug Class | Vaccine |
| 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.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- V116 met non-inferiority criteria compared to PPSV23 for the 12 shared serotypes, with serotype-specific opsonophagocytic antibody geometric mean titres (OPA (Opsonophagocytic Activity)-GMT (Geometric Mean Titer)) ratios measured at 30 days post-vaccination, and demonstrated superiority over PPSV23 for the nine unique serotypes.
- In healthy adults aged 18-49 (Phase 1) and those aged 50 or older (Phase 2), V116 showed consistent effectiveness, achieving both non-inferiority for shared serotypes and superiority for unique serotypes.
- Both age groups demonstrated similar trends in immunogenicity, supporting the potential effectiveness of V116 in preventing pneumococcal disease in adults.
- No vaccine-related serious adverse events or deaths were reported in either phase of the study. The most common adverse event was injection site pain, occurring in 73-77% of V116 recipients in Phase 1 and 46% in Phase 2, compared to 57% and 38% for PPSV23.
- Systemic adverse events like fatigue and myalgia were more common with V116 than PPSV23, with fatigue reported by 27% of V116 recipients in Phase 1 and 19% in Phase 2, compared to 17% and 12% for PPSV23. Most adverse events were mild and resolved within 3 days.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Capvaxive (pneumococcal 21-valent Conjugate Vaccine) Prescribing Information. | 2024 | Merck Sharp & Dohme LLC; Rahway, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial | 600Subjects F: 57% M: 43% | 2023 | The Lancet |
Sex Distribution:
F:57%
M:43%
600Subjects
Year:
2023
Source:The Lancet