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IMOVAX Polio®
IMOVAX Polio® is a Inactivated poliovirus vaccine (IPV) Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of poliomyelitis caused by poliovirus types 1, 2, and 3.
IMOVAX Polio is an inactivated poliovirus vaccine that stimulates the immune system to produce antibodies against all three poliovirus serotypes, providing protection against poliomyelitis.
IMOVAX Polio is an inactivated poliovirus vaccine that stimulates the immune system to produce antibodies against all three poliovirus serotypes, providing protection against poliomyelitis. Used for Prevention of poliomyelitis caused by poliovirus types 1, 2, and 3.
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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 | IMOVAX Polio® |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Inactivated poliovirus vaccine (IPV) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains chemically inactivated (killed) poliovirus particles that cannot cause disease but trigger a humoral immune response. Upon administration, the immune system recognizes these viral antigens and generates neutralizing antibodies against poliovirus types 1, 2, and 3, conferring long-term immunity against infection and disease.
Approved indications
- Prevention of poliomyelitis caused by poliovirus types 1, 2, and 3
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability
- Drowsiness
Key clinical trials
- Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand (PHASE3)
- Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults (PHASE1)
- Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants (PHASE2)
- A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants (PHASE2, PHASE3)
- Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants (PHASE3)
- Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults (PHASE1)
- Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan (PHASE4)
- Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine (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:
- IMOVAX Polio® CI brief — competitive landscape report
- IMOVAX Polio® updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about IMOVAX Polio®
What is IMOVAX Polio®?
How does IMOVAX Polio® work?
What is IMOVAX Polio® used for?
Who makes IMOVAX Polio®?
What drug class is IMOVAX Polio® in?
What development phase is IMOVAX Polio® in?
What are the side effects of IMOVAX Polio®?
Related
- Drug class: All Inactivated poliovirus vaccine (IPV) drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of poliomyelitis caused by poliovirus types 1, 2, and 3
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing