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InfanrixTM hexa
InfanrixTM hexa is a Combination vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.
Infanrix hexa is a combination vaccine that stimulates the immune system to produce antibodies against six infectious diseases by presenting inactivated or toxoid antigens.
InfanrixTM hexa is a vaccine that protects against Hepatitis B, Poliomyelitis, Diphtheria, Acellular Pertussis, Tetanus, and Haemophilus influenzae type b (Hib). It is a small molecule vaccine administered as a primary vaccination course.
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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 hexa |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease Prevention |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains antigens from diphtheria toxoid, tetanus toxoid, acellular pertussis, inactivated poliovirus, hepatitis B surface antigen, and Haemophilus influenzae type b conjugate. These components trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory immune cells against each of these pathogens. The acellular pertussis component uses purified bacterial proteins rather than whole-cell antigen, reducing reactogenicity while maintaining immunogenicity.
Approved indications
- Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability
- Drowsiness
- Loss of appetite
- Vomiting
Key clinical trials
- 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 hexa CI brief — competitive landscape report
- InfanrixTM hexa updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about InfanrixTM hexa
What is InfanrixTM hexa?
How does InfanrixTM hexa work?
What is InfanrixTM hexa used for?
Who makes InfanrixTM hexa?
What drug class is InfanrixTM hexa in?
What development phase is InfanrixTM hexa in?
What are the side effects of InfanrixTM hexa?
Related
- Drug class: All Combination vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease Prevention
- Indication: Drugs for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing