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Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis is a Vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently FDA-approved. Also known as: ADACEL®, NaCl.
The Tdap vaccine works by introducing inactivated toxins from the bacteria that cause tetanus, diphtheria, and pertussis, stimulating the immune system to produce antibodies against these pathogens.
The Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis (Tdap) vaccine, manufactured by Sanofi Pasteur, is designed to protect against tetanus, diphtheria, and pertussis. It is a combination vaccine that contains inactivated toxins from the bacteria causing these diseases. The vaccine is recommended for adolescents and adults as a booster dose. Despite its effectiveness, it has not received an FDA label, which may affect its market presence. Common side effects include pain at the injection site, redness, and swelling, occurring in a significant percentage of recipients. The vaccine is generally well-tolerated but has specific contraindications and interactions that healthcare providers should consider.
At a glance
| Generic name | Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis |
|---|---|
| Also known as | ADACEL®, NaCl |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Vaccine |
| Target | The vaccine targets the immune system to produce antibodies against tetanus, diphtheria, and pertussis toxins. |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains inactivated toxins (toxoids) from Clostridium tetani, Corynebacterium diphtheriae, and acellular components of Bordetella pertussis. These components are not capable of causing disease but trigger an immune response that provides protection against future infections.
Approved indications
Common side effects
- Pain at the injection site
- Redness at the injection site
- Swelling at the injection site
- Headache
- Fatigue
- Muscle aches
Key clinical trials
- Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine (PHASE1, PHASE2)
- A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (PHASE1)
- A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (PHASE1, PHASE2)
- Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults (PHASE3)
- Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial (PHASE2)
- Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents (PHASE3)
- Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa (PHASE4)
- Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US7846441B2 |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis CI brief — competitive landscape report
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- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
What is Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis?
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Related
- Drug class: All Vaccine drugs
- Target: All drugs targeting The vaccine targets the immune system to produce antibodies against tetanus, diphtheria, and pertussis toxins.
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology
- Also known as: ADACEL®, NaCl
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