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REPEVAX™ (Non-concomitant)
REPEVAX™ (Non-concomitant) is a inactivated vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Protection against diphtheria, tetanus, and pertussis in individuals 2 years of age and older.
REPEVAX is a vaccine that protects against diphtheria, tetanus, and pertussis.
REPEVAX is a vaccine used to prevent diphtheria, tetanus, and whooping cough. It is administered as a small molecule vaccine, and its non-concomitant formulation is used in clinical studies for various conditions, including papillomavirus infections and neoplasms.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC 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 | REPEVAX™ (Non-concomitant) |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | inactivated vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
REPEVAX is a combination vaccine that contains inactivated diphtheria and tetanus toxoids and pertussis antigens. It works by stimulating the body's immune system to produce antibodies against these pathogens, providing immunity against diphtheria, tetanus, and pertussis.
Approved indications
- Protection against diphtheria, tetanus, and pertussis in individuals 2 years of age and older
Common side effects
- Pain, redness, or swelling at the injection site
- Fatigue
- Headache
Key clinical trials
- A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007) (PHASE3)
- Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED) (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:
- REPEVAX™ (Non-concomitant) CI brief — competitive landscape report
- REPEVAX™ (Non-concomitant) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about REPEVAX™ (Non-concomitant)
What is REPEVAX™ (Non-concomitant)?
How does REPEVAX™ (Non-concomitant) work?
What is REPEVAX™ (Non-concomitant) used for?
Who makes REPEVAX™ (Non-concomitant)?
What drug class is REPEVAX™ (Non-concomitant) in?
What development phase is REPEVAX™ (Non-concomitant) in?
What are the side effects of REPEVAX™ (Non-concomitant)?
Related
- Drug class: All inactivated vaccine drugs
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Protection against diphtheria, tetanus, and pertussis in individuals 2 years of age and older
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing