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Infanrix + Prevenar 13
Infanrix + Prevenar 13 is a Vaccine combination Biologic drug developed by University Hospital Tuebingen. It is currently in Phase 3 development for Prevention of diphtheria, tetanus, and pertussis in infants and children, Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae in infants and children.
This is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, and 13 serotypes of Streptococcus pneumoniae.
This is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, and 13 serotypes of Streptococcus pneumoniae. Used for Prevention of diphtheria, tetanus, and pertussis in infants and children, Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae in infants and children.
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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.
| 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 | Infanrix + Prevenar 13 |
|---|---|
| Sponsor | University Hospital Tuebingen |
| Drug class | Vaccine combination |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Infanrix is a DTaP (diphtheria, tetanus, acellular pertussis) vaccine containing inactivated toxoids and acellular pertussis antigens. Prevenar 13 is a pneumococcal conjugate vaccine covering 13 serotypes of S. pneumoniae. Together, they provide active immunization by triggering humoral and cellular immune responses to prevent these bacterial infections in infants and young children.
Approved indications
- Prevention of diphtheria, tetanus, and pertussis in infants and children
- Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae in infants and children
Common side effects
- Injection site erythema
- Injection site swelling
- Fever
- Irritability
- Drowsiness
Key clinical trials
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
- Prospective Trial of Vaccine Responses in Childhood Cancer Survivors (PHASE2)
- Fever After Simultaneous Versus Sequential Vaccination in Young Children (PHASE4)
- A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers (PHASE4)
- Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy
- Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines (PHASE4)
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom (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:
- Infanrix + Prevenar 13 CI brief — competitive landscape report
- Infanrix + Prevenar 13 updates RSS · CI watch RSS
- University Hospital Tuebingen portfolio CI
Frequently asked questions about Infanrix + Prevenar 13
What is Infanrix + Prevenar 13?
How does Infanrix + Prevenar 13 work?
What is Infanrix + Prevenar 13 used for?
Who makes Infanrix + Prevenar 13?
What drug class is Infanrix + Prevenar 13 in?
What development phase is Infanrix + Prevenar 13 in?
What are the side effects of Infanrix + Prevenar 13?
Related
- Drug class: All Vaccine combination drugs
- Manufacturer: University Hospital Tuebingen — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of diphtheria, tetanus, and pertussis in infants and children
- Indication: Drugs for Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae in infants and children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing