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Pediarix/Infanrix Penta
Pediarix/Infanrix Penta is a Combination vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children.
Pediarix/Infanrix Penta is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis.
Pediarix/Infanrix Penta is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis. Used for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, 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 | Pediarix/Infanrix Penta |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated toxoids of diphtheria and tetanus, acellular pertussis antigens, hepatitis B surface antigen, and inactivated poliovirus types 1, 2, and 3. These components trigger adaptive immune responses, generating humoral and cellular immunity to protect against these five infectious diseases. The vaccine is administered intramuscularly in infants and young children as part of routine immunization schedules.
Approved indications
- Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability
- Drowsiness
- Loss of appetite
Key clinical trials
- Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine (PHASE3)
- Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children (PHASE4)
- Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age (PHASE3)
- Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age. (PHASE3)
- Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC (PHASE3)
- Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants (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:
- Pediarix/Infanrix Penta CI brief — competitive landscape report
- Pediarix/Infanrix Penta updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Pediarix/Infanrix Penta
What is Pediarix/Infanrix Penta?
How does Pediarix/Infanrix Penta work?
What is Pediarix/Infanrix Penta used for?
Who makes Pediarix/Infanrix Penta?
What drug class is Pediarix/Infanrix Penta in?
What development phase is Pediarix/Infanrix Penta in?
What are the side effects of Pediarix/Infanrix Penta?
Related
- Drug class: All Combination vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing