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PCV21
PCV21 is a pneumococcal conjugate vaccine that stimulates immune responses against 21 serotypes of Streptococcus pneumoniae to prevent pneumococcal disease.
PCV21 is a pneumococcal conjugate vaccine that stimulates immune responses against 21 serotypes of Streptococcus pneumoniae to prevent pneumococcal disease. Used for Prevention of pneumococcal disease in adults, Prevention of invasive pneumococcal disease, pneumonia, and otitis media.
At a glance
| Generic name | PCV21 |
|---|---|
| Also known as | Capvaxive |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Pneumococcal conjugate vaccine |
| Target | Streptococcus pneumoniae polysaccharide capsule (21 serotypes) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
PCV21 contains polysaccharide capsules from 21 different serotypes of Streptococcus pneumoniae conjugated to a protein carrier, which enhances immunogenicity. The vaccine triggers both humoral and cellular immune responses, generating antibodies and T-cell memory against these serotypes. This provides protection against invasive pneumococcal disease, pneumonia, and other infections caused by these bacterial serotypes.
Approved indications
- Prevention of pneumococcal disease in adults
- Prevention of invasive pneumococcal disease, pneumonia, and otitis media
Common side effects
- Injection site pain
- Injection site erythema
- Injection site swelling
- Myalgia
- Fatigue
- Headache
Key clinical trials
- Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49 (PHASE3)
- Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines (PHASE4)
- Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age (PHASE3)
- Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PCV21 CI brief — competitive landscape report
- PCV21 updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI