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GSK Biologicals' Synflorix™
Synflorix is a pneumococcal conjugate vaccine that stimulates immune responses against multiple serotypes of Streptococcus pneumoniae to prevent pneumococcal disease.
Synflorix is a pneumococcal conjugate vaccine that stimulates immune responses against multiple serotypes of Streptococcus pneumoniae to prevent pneumococcal disease. Used for Prevention of invasive pneumococcal disease in infants and children, Prevention of pneumococcal otitis media, Prevention of pneumococcal pneumonia in pediatric populations.
At a glance
| Generic name | GSK Biologicals' Synflorix™ |
|---|---|
| Also known as | 10Pn |
| Sponsor | GlaxoSmithKline |
| Drug class | Pneumococcal conjugate vaccine |
| Target | Streptococcus pneumoniae polysaccharide antigens (serotypes 1, 5, 6B, 7F, 9V, 14, 19F, 19A, 23F, and others) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Synflorix contains polysaccharide antigens from 13 serotypes of Streptococcus pneumoniae conjugated to a protein carrier (protein D from Haemophilus influenzae type b), which enhances immunogenicity and T-cell dependent responses. The vaccine primes both humoral and cellular immunity to reduce the risk of invasive pneumococcal disease, pneumonia, and otitis media caused by vaccine-covered serotypes.
Approved indications
- Prevention of invasive pneumococcal disease in infants and children
- Prevention of pneumococcal otitis media
- Prevention of pneumococcal pneumonia in pediatric populations
Common side effects
- Injection site erythema
- Injection site swelling
- Fever
- Irritability
- Drowsiness
- Loss of appetite
Key clinical trials
- Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™ (PHASE3)
- Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers (PHASE1)
- Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines (PHASE3)
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose (PHASE2)
- Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age (PHASE2)
- Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam (PHASE3)
- Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine (PHASE3)
- Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™ (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:
- GSK Biologicals' Synflorix™ CI brief — competitive landscape report
- GSK Biologicals' Synflorix™ updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI