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Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)

Generic Name
Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)
Brand Names
Adacel, Boostrix, Daptacel, Diphtheria and Tetanus Toxoids Adsorbed, Infanrix, Kinrix, Pediarix, Pentacel, Quadracel, Td Adsorbed, Tdvax, Tenivac, Vaxelis, Infanrix Hexa
Drug Type
Biotech
CAS Number
308079-75-6
Unique Ingredient Identifier
IRH51QN26H

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

  • Diphtheria
  • Tetanus

Research Report

Published: Jul 22, 2025

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

Continue reading the full research report

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

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

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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