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Clostridium difficile vaccine
Clostridium difficile vaccine is a Bacterial vaccine Biologic drug developed by Sanofi. It is currently in Phase 3 development for Prevention of Clostridium difficile infection (CDI), Prevention of recurrent Clostridium difficile infection.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against Clostridium difficile toxins and bacterial antigens to prevent infection and disease.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against Clostridium difficile toxins and bacterial antigens to prevent infection and disease. Used for Prevention of Clostridium difficile infection (CDI), Prevention of recurrent Clostridium difficile infection.
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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 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 | Clostridium difficile vaccine |
|---|---|
| Sponsor | Sanofi |
| Drug class | Bacterial vaccine |
| Target | Clostridium difficile toxins A and B and bacterial antigens |
| Modality | Biologic |
| Therapeutic area | Infectious Disease / Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine is designed to elicit protective immune responses against C. difficile, a bacterium that causes severe gastrointestinal infections, particularly in hospitalized and elderly patients. By targeting bacterial toxins (toxins A and B) and/or other immunogenic antigens, the vaccine aims to prevent colonization, reduce disease severity, or prevent recurrent infections in vaccinated individuals.
Approved indications
- Prevention of Clostridium difficile infection (CDI)
- Prevention of recurrent Clostridium difficile infection
Common side effects
- Injection site reactions (pain, erythema, swelling)
- Fever
- Myalgia
- Fatigue
Key clinical trials
- A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older (PHASE3)
- To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons That Will Be Given to Healthy Adults (PHASE1, PHASE2)
- A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy (NA)
- Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years (PHASE1)
- Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (PHASE3)
- Clostridium Difficile Vaccine Efficacy Trial (PHASE3)
- Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age (PHASE3)
- Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (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:
- Clostridium difficile vaccine CI brief — competitive landscape report
- Clostridium difficile vaccine updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Clostridium difficile vaccine
What is Clostridium difficile vaccine?
How does Clostridium difficile vaccine work?
What is Clostridium difficile vaccine used for?
Who makes Clostridium difficile vaccine?
What drug class is Clostridium difficile vaccine in?
What development phase is Clostridium difficile vaccine in?
What are the side effects of Clostridium difficile vaccine?
What does Clostridium difficile vaccine target?
Related
- Drug class: All Bacterial vaccine drugs
- Target: All drugs targeting Clostridium difficile toxins A and B and bacterial antigens
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Immunology
- Indication: Drugs for Prevention of Clostridium difficile infection (CDI)
- Indication: Drugs for Prevention of recurrent Clostridium difficile infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing