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InfanrixTM IPV
InfanrixTM IPV is a Combination vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children.
Infanrix IPV is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, and poliovirus.
Infanrix IPV is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, and poliovirus. Used for Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis 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. -
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 | InfanrixTM IPV |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated toxoids of diphtheria and tetanus, acellular pertussis antigens, and inactivated poliovirus particles. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory B cells against these four pathogens. This provides immunological protection against diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis.
Approved indications
- Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability or fussiness
- Drowsiness
- Loss of appetite
Key clinical trials
- Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia (PHASE4)
- 3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age (PHASE2)
- Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines (PHASE3)
- Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course (PHASE4)
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:
- InfanrixTM IPV CI brief — competitive landscape report
- InfanrixTM IPV updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about InfanrixTM IPV
What is InfanrixTM IPV?
How does InfanrixTM IPV work?
What is InfanrixTM IPV used for?
Who makes InfanrixTM IPV?
What drug class is InfanrixTM IPV in?
What development phase is InfanrixTM IPV in?
What are the side effects of InfanrixTM IPV?
Related
- Drug class: All Combination vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing