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DTPa-IPV
DTPa-IPV is a Combination vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Primary immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children, Booster immunization in childhood. Also known as: Infanrix™-IPV.
DTPa-IPV is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, and poliovirus.
DTPa-IPV is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, and poliovirus. Used for Primary immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children, Booster immunization in childhood.
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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 | DTPa-IPV |
|---|---|
| Also known as | Infanrix™-IPV |
| Sponsor | GlaxoSmithKline |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease Prevention |
| Phase | Phase 3 |
Mechanism of action
This is a multi-component inactivated vaccine containing diphtheria and tetanus toxoids, acellular pertussis antigens, and inactivated poliovirus antigens. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory immune cells against these four pathogens.
Approved indications
- Primary immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children
- Booster immunization in childhood
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability or fussiness
- Drowsiness
- Loss of appetite
Key clinical trials
- Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (PHASE3)
- Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis (NA)
- 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
- A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants (PHASE2)
- Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™ (PHASE4)
- Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines (PHASE3)
- Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) (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:
- DTPa-IPV CI brief — competitive landscape report
- DTPa-IPV updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about DTPa-IPV
What is DTPa-IPV?
How does DTPa-IPV work?
What is DTPa-IPV used for?
Who makes DTPa-IPV?
Is DTPa-IPV also known as anything else?
What drug class is DTPa-IPV in?
What development phase is DTPa-IPV in?
What are the side effects of DTPa-IPV?
Related
- Drug class: All Combination vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease Prevention
- Indication: Drugs for Primary immunization against diphtheria, tetanus, pertussis, and poliomyelitis in infants and children
- Indication: Drugs for Booster immunization in childhood
- Also known as: Infanrix™-IPV
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing