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Prevenar 13 (2-Dose)
Prevenar 13 (2-Dose) is a Pneumococcal conjugate vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of invasive pneumococcal disease in infants and children, Prevention of pneumococcal pneumonia and otitis media.
Prevenar 13 is a pneumococcal conjugate vaccine that stimulates the immune system to produce antibodies against 13 serotypes of Streptococcus pneumoniae.
Prevenar 13 (2-Dose) is a 13-valent pneumococcal conjugate vaccine used to prevent pneumococcal disease, which is a type of bacterial infection. It is also studied for its potential to prevent other bacterial infections such as Neisseria Meningitidis and Salmonella infections.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Prevenar 13 (2-Dose) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Pneumococcal conjugate vaccine |
| Target | Streptococcus pneumoniae capsular polysaccharides (13 serotypes) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains capsular polysaccharides from 13 serotypes of pneumococcus conjugated to a carrier protein (CRM197), which enhances immunogenicity by promoting T-cell dependent responses. This elicits both humoral and cellular immunity, providing protection against invasive pneumococcal disease, pneumonia, and otitis media caused by these serotypes. The 2-dose formulation is designed for specific age groups or populations requiring abbreviated immunization schedules.
Approved indications
- Prevention of invasive pneumococcal disease in infants and children
- Prevention of pneumococcal pneumonia and otitis media
Common side effects
- Injection site erythema
- Injection site swelling
- Fever
- Irritability
- Drowsiness
Key clinical trials
- A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks) (PHASE3)
- 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)
- Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (PHASE3)
- A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PHASE1)
- Clinical Trial of PCV24 in Children Aged 2-17 Years (PHASE1)
- A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants (PHASE2)
- Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (PHASE3)
- PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prevenar 13 (2-Dose) CI brief — competitive landscape report
- Prevenar 13 (2-Dose) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Prevenar 13 (2-Dose)
What is Prevenar 13 (2-Dose)?
How does Prevenar 13 (2-Dose) work?
What is Prevenar 13 (2-Dose) used for?
Who makes Prevenar 13 (2-Dose)?
What drug class is Prevenar 13 (2-Dose) in?
What development phase is Prevenar 13 (2-Dose) in?
What are the side effects of Prevenar 13 (2-Dose)?
What does Prevenar 13 (2-Dose) target?
Related
- Drug class: All Pneumococcal conjugate vaccine drugs
- Target: All drugs targeting Streptococcus pneumoniae capsular polysaccharides (13 serotypes)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of invasive pneumococcal disease in infants and children
- Indication: Drugs for Prevention of pneumococcal pneumonia and otitis media
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing