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PCV13 alone
PCV13 is a pneumococcal conjugate vaccine that stimulates the immune system to produce antibodies against 13 serotypes of Streptococcus pneumoniae.
PCV13 is a pneumococcal conjugate vaccine that stimulates the immune system to produce antibodies against 13 serotypes of Streptococcus pneumoniae. Used for Prevention of invasive pneumococcal disease in adults ≥50 years, Prevention of pneumococcal pneumonia in adults ≥50 years, Prevention of invasive pneumococcal disease in children 2-59 months.
At a glance
| Generic name | PCV13 alone |
|---|---|
| Sponsor | Korea University Guro Hospital |
| Drug class | Pneumococcal conjugate vaccine |
| Target | Streptococcus pneumoniae polysaccharide capsule (13 serotypes) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
PCV13 contains polysaccharide capsules from 13 serotypes of pneumococcus conjugated to a protein carrier, which enhances immunogenicity and T-cell dependent responses. Upon vaccination, the immune system generates both humoral (antibody) and cellular immunity against these serotypes, providing protection against invasive pneumococcal disease and pneumococcal pneumonia caused by the covered serotypes.
Approved indications
- Prevention of invasive pneumococcal disease in adults ≥50 years
- Prevention of pneumococcal pneumonia in adults ≥50 years
- Prevention of invasive pneumococcal disease in children 2-59 months
Common side effects
- Injection site erythema
- Injection site swelling
- Injection site pain
- Myalgia
- Fatigue
- Headache
- Fever
Key clinical trials
- Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer (PHASE1, PHASE2)
- A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age (PHASE3)
- A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age (PHASE3)
- Innovative Anti-pneumococcal Vaccine Strategies in Patients With ANCA-associated Vasculitis Receiving Rituximab Therapy (PHASE2)
- Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand (PHASE3)
- Trial of Antibody Responses by Vitamin Supplementation (PHASE1)
- Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma (PHASE4)
- Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT) (NA)
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 |