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Poliorix
Poliorix is a Inactivated viral vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development. Also known as: IPV.
Inactivated poliovirus vaccine that stimulates the immune system to produce antibodies against poliovirus types 1, 2, and 3.
Poliorix is an inactivated poliomyelitis vaccine used in combination with other vaccines, such as Infanrix-IPV/Hib and Infanrix Hib, to protect against multiple diseases including poliomyelitis, tetanus, diphtheria, and Haemophilus influenzae type b. It has been studied in clinical trials, including a post-marketing safety study in Korean children, to monitor its safety and reactogenicity.
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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). -
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 | Poliorix |
|---|---|
| Also known as | IPV |
| Sponsor | GlaxoSmithKline |
| Drug class | Inactivated viral vaccine |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Poliorix contains inactivated (killed) poliovirus strains that cannot cause disease but retain their antigenic properties. Upon administration, the vaccine stimulates the body's immune system to produce neutralizing antibodies against the three poliovirus types, providing protective immunity against poliomyelitis infection.
Approved indications
Common side effects
Key clinical trials
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine (PHASE3)
- Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers (PHASE2)
- Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia (PHASE4)
- Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines (PHASE3)
- Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants (PHASE1)
- Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine (PHASE3)
- Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults (PHASE4)
- Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine (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:
- Poliorix CI brief — competitive landscape report
- Poliorix updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Poliorix
What is Poliorix?
How does Poliorix work?
Who makes Poliorix?
Is Poliorix also known as anything else?
What drug class is Poliorix in?
What development phase is Poliorix in?
Related
- Drug class: All Inactivated viral vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: IPV
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing