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Research Report
An Overview of Diphtheria, Tetanus, and Pertussis Vaccines Manufactured by Sanofi Pasteur
I. Introduction
A. Diphtheria, Tetanus, and Pertussis: Etiology and Public Health Significance
Diphtheria, tetanus, and pertussis are serious infectious diseases that have historically imposed a significant burden on global public health. Understanding their etiology is crucial to appreciating the role of vaccination.
Diphtheria is an acute, toxin-mediated illness caused by toxigenic strains of the bacterium Corynebacterium diphtheriae. The bacterium typically colonizes the mucous membranes of the respiratory tract, leading to symptoms such as sore throat, fever, and the formation of a characteristic pseudomembrane, often in the pharynx or larynx. The primary virulence factor is diphtheria toxin, an exotoxin that inhibits protein synthesis in host cells, leading to tissue damage and potentially severe systemic complications, including myocarditis and neuropathy. Protection against diphtheria is primarily mediated by the presence of neutralizing antibodies against this toxin.[1] A serum diphtheria antitoxin level of
0.01 IU/mL is considered to confer some level of protection, while levels of ≥0.1 IU/mL are generally regarded as protective, and levels of 1.0 IU/mL are associated with long-term protection.[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/30 | Phase 4 | Recruiting | Dimitri Diavatopoulos | ||
2014/05/23 | Phase 4 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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