Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
- Diphtheria
- Tetanus
Research Report
Corynebacterium diphtheriae Toxoid Antigen (DB10584): A Comprehensive Monograph on its Biochemistry, Clinical Application, and Public Health Significance
Executive Summary & Introduction
Overview of Diphtheria
Diphtheria is an acute, toxin-mediated infectious disease caused by toxigenic strains of the bacterium Corynebacterium diphtheriae.[1] The disease classically manifests in the upper respiratory tract, particularly the nasopharynx, or on the skin.[1] Its hallmark clinical sign is the formation of a dense, gray, adherent pseudomembrane composed of fibrin, bacteria, and inflammatory cells, which covers the pharynx and tonsils.[1] This pseudomembrane can cause severe breathing difficulties and, in advanced cases, lead to airway obstruction and death by suffocation.[4]
The primary virulence factor and the cause of systemic disease is a potent exotoxin secreted by the bacterium.[1] Once absorbed into the circulatory system, the diphtheria toxin is distributed to distant organs, where it can elicit severe and life-threatening complications, including myocarditis (inflammation of the heart muscle) leading to congestive heart failure, and peripheral neuropathy causing paralysis.[1] With a fatality rate of 5-10%, which can be even higher in young children, diphtheria remains a serious global health threat, particularly in regions with inadequate immunization coverage.[7]
The Diphtheria Toxoid: A Cornerstone of Modern Vaccinology
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/30 | Phase 1 | Recruiting | |||
2025/02/13 | Phase 3 | Recruiting | |||
2025/02/13 | Phase 3 | Recruiting | |||
2024/12/16 | Phase 3 | Recruiting | |||
2024/09/19 | Phase 4 | Completed | |||
2022/03/03 | Phase 4 | Active, not recruiting | Farzanah Laher | ||
2021/07/27 | Phase 4 | Completed | |||
2018/08/08 | Phase 3 | Completed | |||
2015/09/07 | Phase 1 | Completed | |||
2014/05/23 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
A-S Medication Solutions | 50090-7541 | INTRAMUSCULAR | 25 [iU] in 0.5 mL | 8/13/2025 | |
GlaxoSmithKline Biologicals SA | 58160-812 | INTRAMUSCULAR | 25 [iU] in 0.5 mL | 11/26/2024 | |
A-S Medication Solutions | 50090-1377 | INTRAMUSCULAR | 2.5 [iU] in 0.5 mL | 3/31/2025 | |
A-S Medication Solutions | 50090-1079 | INTRAMUSCULAR | 2 [Lf] in 0.5 mL | 10/22/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/17/2013 | ||
Authorised | 10/23/2000 | ||
Authorised | 2/15/2016 | ||
Authorised | 4/17/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE | SIN15479P | INJECTION, SUSPENSION | 2Lf | 5/8/2018 | |
BOOSTAGEN SUSPENSION FOR INJECTION | SIN16493P | INJECTION, SUSPENSION | 2.0 Lf/0.5 ml | 5/18/2022 | |
PENTAXIM VACCINE | SIN14795P | INJECTION, POWDER, FOR SUSPENSION | min. 30 IU/0.5 mL | 6/5/2015 | |
BOOSTRIX VACCINE | SIN11845P | INJECTION | 2 iu/0.5 ml | 3/9/2002 | |
INFANRIX IPV+HIB VACCINE | SIN10988P | INJECTION | min 30IU/0.5ml | 6/25/1999 | |
Tetraxim Vaccine | SIN15026P | INJECTION, SUSPENSION | Minimum 30 IU/0.5ml | 6/6/2016 | |
Adacel®, Suspension for Injection | SIN14232P | INJECTION, SUSPENSION | 2 Lf | 9/20/2012 | |
Synflorix Suspension for Injection (Prefilled Syringe) | SIN13775P | INJECTION, SUSPENSION | 3-6 μg DT/dose (total DT content) | 3/19/2010 | |
HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE | SIN14834P | INJECTION, SUSPENSION | 30 Lf (>= 20 IU)/0.5 mL | 8/25/2015 | |
INFANRIX HEXA VACCINE | SIN12288P | INJECTION | min 30 iu/0.5 ml | 5/7/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ADACEL POLIO VACCINE | N/A | N/A | N/A | 5/15/2008 | |
BOOSTRIX VACCINE | N/A | N/A | N/A | 8/8/2001 | |
BOOSTRIX POLIO VACCINE | N/A | N/A | N/A | 5/31/2007 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
BOOSTRIX | 02247600 | Suspension - Intramuscular | 2 UNIT / 0.5 ML | 5/29/2007 | |
DIPHTHERIA TOXOID | aventis pasteur limited | 00074853 | Liquid - Subcutaneous | 50 LF / ML | 12/31/1925 |
DPT POLIO ADSORBED VACCINES | aventis pasteur limited | 00605050 | Liquid - Intramuscular | 25 LF / 0.5 ML | 12/31/1984 |
DIPHTHERIA TOXOID IMMUNIZATION OF REACTORS | aventis pasteur limited | 00074845 | Liquid - Subcutaneous | 4 LF / ML | 12/31/1933 |
INFANRIX-IPV | 02241284 | Suspension - Intramuscular | 30 UNIT / 0.5 ML | 10/25/2012 | |
TD ADSORBED | 02528401 | Suspension - Intramuscular | 2 LF / 0.5 ML | 4/9/2024 | |
PROHIBIT INJ VACCINE | aventis pasteur limited | 00764221 | Liquid - Intramuscular | 23 MCG / 0.5 ML | 12/31/1988 |
QUADRACEL | 02534789 | Suspension - Intramuscular | 15 LF / 0.5 ML | 5/6/2024 | |
PEDIACEL | 02243167 | Suspension - Intramuscular | 15 LF / 0.5 ML | 10/4/2007 | |
BOOSTRIX-POLIO | 02312557 | Suspension - Intramuscular | 2.5 LF / 0.5 ML | 10/22/2010 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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