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PR5I
PR5I is a therapeutic vaccine designed to stimulate immune responses against pneumococcal serotypes to prevent pneumococcal disease.
PR5I is a therapeutic vaccine designed to stimulate immune responses against pneumococcal serotypes to prevent pneumococcal disease. Used for Prevention of pneumococcal disease.
At a glance
| Generic name | PR5I |
|---|---|
| Also known as | V419, Vaxelis®, DTaP-HB-IPV-Hib |
| Sponsor | MCM Vaccines B.V. |
| Drug class | Therapeutic vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
As a vaccine candidate from MCM Vaccines, PR5I likely works by presenting pneumococcal antigens to the immune system to generate protective antibody and cellular immune responses. This approach aims to provide broader serotype coverage or improved immunogenicity compared to existing pneumococcal vaccines, potentially offering enhanced protection against invasive pneumococcal disease.
Approved indications
- Prevention of pneumococcal disease
Common side effects
- Injection site reactions
- Fever
- Myalgia
Key clinical trials
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) (PHASE3)
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) (PHASE3)
- Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011) (PHASE3)
- Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010) (PHASE3)
- Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® (PHASE2)
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 |