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HBVAXPRO 5µg
HBVAXPRO 5µg is a Recombinant hepatitis B vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently in Phase 3 development for Prevention of hepatitis B infection in infants, children, and adults. Also known as: Hepatitis B vaccine (rDNA).
HBVAXPRO is a recombinant hepatitis B surface antigen vaccine that stimulates the immune system to produce antibodies against hepatitis B virus.
HBVAXPRO is a recombinant hepatitis B surface antigen vaccine that stimulates the immune system to produce antibodies against hepatitis B virus. Used for Prevention of hepatitis B infection in infants, children, and adults.
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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
Sanofi Pasteur, a Sanofi Company 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 | HBVAXPRO 5µg |
|---|---|
| Also known as | Hepatitis B vaccine (rDNA) |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Recombinant hepatitis B vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains hepatitis B surface antigen (HBsAg) produced through recombinant DNA technology in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) against hepatitis B virus infection. This provides active immunization and long-term protection against hepatitis B disease.
Approved indications
- Prevention of hepatitis B infection in infants, children, and adults
Common side effects
- Injection site soreness or swelling
- Fever
- Fatigue
- Headache
- Myalgia
Key clinical trials
- Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (PHASE1, PHASE2)
- Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines (PHASE1)
- Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine (PHASE4)
- Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA (PHASE3)
- Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED) (PHASE3)
- Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B 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:
- HBVAXPRO 5µg CI brief — competitive landscape report
- HBVAXPRO 5µg updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about HBVAXPRO 5µg
What is HBVAXPRO 5µg?
How does HBVAXPRO 5µg work?
What is HBVAXPRO 5µg used for?
Who makes HBVAXPRO 5µg?
Is HBVAXPRO 5µg also known as anything else?
What drug class is HBVAXPRO 5µg in?
What development phase is HBVAXPRO 5µg in?
What are the side effects of HBVAXPRO 5µg?
What does HBVAXPRO 5µg target?
Related
- Drug class: All Recombinant hepatitis B vaccine drugs
- Target: All drugs targeting Hepatitis B surface antigen (HBsAg)
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of hepatitis B infection in infants, children, and adults
- Also known as: Hepatitis B vaccine (rDNA)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing