diphtheria toxoid
Vaccineapproved
Approved
Jun 24, 2008
Diphtheria vaccine is a toxoid vaccine against diphtheria, an illness caused by Corynebacterium diphtheriae. Its use has resulted in a more than 90% decrease in number of cases globally between 1980 and 2000. The first dose is recommended at six weeks of age with two additional doses four weeks apart, after which it is about 95% effective during childhood. Three further doses are recommended during childhood. It is unclear if further doses later in life are needed. — Wikipedia
Clinical trial activity
37 trials · 31 clinical orgs · 2 marketing orgs
Phase 1
6
Phase 2
25
Phase 3
15
Phase 4
8
Earliest trial started Jul 14, 2000 (NCT00006066)
Timeline
1920s
- Jul 1, 1926
Evidence of US Marketing
2000s
- Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2003
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
- Jun 24, 2008
GlaxoSmithKline — Earliest FDA Approval
- Jun 24, 2008
GlaxoSmithKline — NDA Secondary Org
- Jun 24, 2008
GlaxoSmithKline — NDA Organization
2010s
- Mar 24, 2015
Sanofi-Aventis — NDA Secondary Org
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 2
- Clostridium Infections · Phase 2
- Diphtheria · Phase 4
- Diphtheria-Tetanus-acellular Pertussis Vaccines · Phase 3
- Diphtheria-Tetanus-Pertussis Vaccine · Phase 3
- Diphtheria Toxoid · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Haemophilus Infections · Phase 3
- Haemophilus influenzae type b · Phase 3
- Hamartoma · Phase 2
- Hepatitis B · Phase 3
- HIV Infections · Phase 1
- Influenza, Human · Phase 3
- Kidney Transplantation · Phase 4
- Lung Neoplasms · Phase 1/Phase 2
- Malaria · Phase 3
- Meningitis, Meningococcal · Phase 4
- Meningococcal Infections · Phase 4
- Multiple Sclerosis · Phase 4
- Ovarian Neoplasms · Phase 2
- Pertussis Vaccine · Phase 4
- Pneumococcal Infections · Phase 4
- Poliomyelitis · Phase 3
- Rotavirus Infections · Phase 3
- Tetanus · Phase 4
- Typhoid Fever · Phase 1/Phase 2
- Vaccines · Phase 4
- Whooping Cough · Phase 3
Mechanism of action
- Diphtheria toxoidVACCINE ANTIGEN
Diphtheria toxoid vaccine antigen
- Diphtheria toxinImmunity, active
Diphtheria toxin immunity, active
Approval history
- approvedJun 24, 2008
- approvedJul 1, 1926
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaDiphtheria vaccine ↗
- ChEMBLCHEMBL2109121 ↗
- WikipediaDiphtheria toxin ↗
- WikipediaDiphtheria ↗
Also known as
- diphtheria
- diphtheria
- diphtheria toxin
- diphtheriatoxoid
- diphtheria toxoid
- diphtheria toxoid
- diphtheria toxoid, formalin treated
- ditanrix
- tritanrix
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07147400 | Phase 2 | Aug 22, 2025 | National Institute of Allergy and Infectious Diseases (NIAID), Serum Institute of India Pvt. Ltd. |
| NCT06639074 | Phase 2 | Nov 12, 2024 | Mayo Clinic |
| NCT06507605 | Phase 1 | Jul 30, 2024 | National Institute of Allergy and Infectious Diseases (NIAID), Serum Institute of India Pvt. Ltd. |
| NCT06056050 | Phase 1 | Dec 6, 2023 | Tianjin Cansino Biotechnology Inc |
| NCT05870618 | Phase 4 | May 31, 2023 | China National Biotec Group Co., Ltd, Government of China |
| NCT05870631 | Phase 4 | May 31, 2023 | China National Biotec Group Co., Ltd, Government of China |
| NCT05480462 | Phase 3 | Aug 31, 2022 | IBSS Biomed S.A. |
| NCT05475379 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2022 | International Center for Diarrheal Disease Research |
| NCT03927222 | Phase 2 | Jun 30, 2019 | Duke University |
| NCT03589768 | Phase 2 | Oct 18, 2018 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT03694405 | Phase 4 | Sep 20, 2018 | Canadian Center for Vaccinology, Canadian Immunization Research Network, Canadian Institutes of Health Research (CIHR), Dalhousie University, Provincial Health Services Authority, University of British Columbia, University of Calgary |
| NCT02864368 | Phase 1 | Dec 1, 2016 | Annias Immunotherapeutics, Inc., Duke University, National Cancer Institute (NCI), National Institutes of Health (NIH) |
| NCT02465268 | Phase 2 | Aug 1, 2016 | National Cancer Institute (NCI), University of Florida |
| NCT02366728 | Phase 2 | Sep 1, 2015 | Duke University |
| NCT02333474 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2015 | Jinan University |
| NCT02118961 | Phase 3 | Apr 1, 2014 | Mitsubishi Tanabe, Osaka University |
| NCT03552445 | Phase 4 | Nov 1, 2013 | Korea University |
| NCT01353703 | Phase 3 | Apr 1, 2012 | GlaxoSmithKline |
| NCT01424644 | Phase 4 | Sep 1, 2011 | Novartis |
| NCT01003431 | Phase 3 | Dec 1, 2009 | Merck |
Showing 20 of 37 trials
Page 1 / 2
Organizations
Research & Development (31)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 12 | 12 | 3 | 2003 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 4 | 2 | 2 | 2000 |
| Duke University | Academic/Hospital | 3 | 3 | 2 | 2015 |
| Sanofi | For profit | 3 | 3 | 1 | 2006 |
| China National Biotec Group Co., Ltd | For profit | 2 | 0 | 1 | 2023 |
| Government of China | Government | 2 | 2 | 1 | 2023 |
| National Cancer Institute (NCI) | Government | 2 | 0 | 2 | 2016 |
| National Institutes of Health (NIH) | Government | 2 | 0 | 1 | 2000 |
| Serum Institute of India Pvt. Ltd. | For profit | 2 | 2 | 2 | 2024 |
| Annias Immunotherapeutics, Inc. | For profit | 1 | 0 | 1 | 2016 |
| Biogen | For profit | 1 | 1 | 1 | 2008 |
| Canadian Center for Vaccinology | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Canadian Immunization Research Network | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Dalhousie University | Academic/Hospital | 1 | 0 | 1 | 2018 |
| IBSS Biomed S.A. | For profit | 1 | 1 | 1 | 2022 |
| International Center for Diarrheal Disease Research | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Jinan University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Korea University | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2024 |
31 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | Jun 24, 2008 |
| GlaxoSmithKline | For profit | NDA | Jun 24, 2008 |
| Sanofi-Aventis | For profit | NDA2 | Mar 24, 2015 |