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TT Vaccine
TT Vaccine is a inactivated vaccine Biologic drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Prevention of diphtheria and tetanus.
The TT vaccine works by stimulating the body to produce antibodies against diphtheria and tetanus toxins.
The TT Vaccine, also known as Hib-MenCY-TT, is a conjugate vaccine that protects against Haemophilus influenzae type b, Neisseria meningitidis serogroups C and Y, and pertussis. It is a small molecule vaccine that has been studied in clinical trials for safety and efficacy in infants as young as 12 to 15 months old.
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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
Hoffmann-La Roche 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 | TT Vaccine |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | inactivated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This is achieved through the introduction of inactivated diphtheria and tetanus toxins, which trigger an immune response and provide long-term protection against these diseases.
Approved indications
- Prevention of diphtheria and tetanus
Common side effects
- Pain, redness, or swelling at the injection site
Key clinical trials
- Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (PHASE3)
- A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks) (PHASE3)
- Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PHASE1)
- Maternal Determinants of Infant Immunity to Pertussis (PHASE4)
- MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults (PHASE4)
- Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy (PHASE4)
- Infant Malaria Vaccine Schedule Optimization (PHASE2)
- A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants (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:
- TT Vaccine CI brief — competitive landscape report
- TT Vaccine updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about TT Vaccine
What is TT Vaccine?
How does TT Vaccine work?
What is TT Vaccine used for?
Who makes TT Vaccine?
What drug class is TT Vaccine in?
What development phase is TT Vaccine in?
What are the side effects of TT Vaccine?
Related
- Drug class: All inactivated vaccine drugs
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of diphtheria and tetanus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing