acellular pertussis vaccine
Trade name: ACEL-IMUNE\T
Approved
Feb 7, 1992
Pertussis vaccine is a vaccine that protects against whooping cough (pertussis). There are two main types: whole-cell vaccines and acellular vaccines. The whole-cell vaccine is about 78% effective while the acellular vaccine is 71–85% effective. The effectiveness of the vaccines appears to decrease by between 2 and 10% per year after vaccination, with a more rapid decrease with the acellular vaccines. The vaccine is only available in combination with tetanus and diphtheria vaccines. Pertussis vaccine is estimated to have saved over 500,000 lives in 2002. — Wikipedia
Clinical trial activity
14 trials · 16 clinical orgs · 2 marketing orgs
Earliest trial started Sep 1, 1997 (NCT01267058)
Timeline
1990s
- Feb 7, 1992
Earliest FDA Approval
- Jan 1, 1997
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
2000s
- Jun 24, 2008
GlaxoSmithKline — First NDA Organization
- Jun 24, 2008
GlaxoSmithKline — NDA Secondary Org
- Jun 24, 2008
GlaxoSmithKline — NDA Organization
2010s
- Jan 1, 2010
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
- Mar 24, 2015
Sanofi-Aventis — NDA Secondary Org
Indications
Approved for
Studied for
- Clostridium Infections · Phase 2
- Diphtheria · Phase 3
- Diphtheria-Tetanus-acellular Pertussis Vaccines · Phase 3
- Diphtheria-Tetanus-Pertussis Vaccine · Phase 3
- Diphtheria Toxoid · Phase 2
- Haemophilus influenzae type b · Phase 3
- Hepatitis B · Phase 3
- Immunization · Phase 4
- Immunoglobulins · Phase 4
- Maternal-Fetal Relations · Phase 4
- Meningitis, Meningococcal · Phase 4
- Pertussis Vaccine · Phase 3
- Poliomyelitis · Phase 3
- Pregnancy Complications · Phase 4
- Rotavirus Infections · Phase 2
- Tetanus · Phase 3
- Trismus · Phase 1
- Vaccination · Phase 4
- Whooping Cough · Phase 4
Mechanism of action
- Bordetella pertussisImmunity, active
Bordetella pertussis immunity, active
Approval history
- approvedFeb 7, 1992
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaPertussis vaccine ↗
Also known as
- acellular pertussis vaccine
- gsk-251154 vaccine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06798831 | Phase 3 | Feb 8, 2025 | BioNet-Asia Co., Ltd. |
| NCT06903221 | Phase 4 | Oct 16, 2024 | Radboud University |
| NCT05856396 | Phase 4 | Jun 1, 2023 | Free University of Brussels |
| NCT04793620 | Phase 1 | Apr 6, 2021 | Adjuvance Technologies, Inc. |
| NCT03908164 | Phase 4 | Apr 12, 2019 | Department of Health, United Kingdom, Thrasher Research Fund, University of London |
| NCT03589768 | Phase 2 | Oct 18, 2018 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT03606096 | Phase 4 | Sep 30, 2018 | Imperial College London, Leiden University, National Institute for Public Health and the Environment, RIVM, Holland, Radboud University, University of London, University of Oxford, University of Turku |
| NCT02382913 | Phase 1 | Apr 1, 2015 | Novartis |
| NCT01353703 | Phase 3 | Apr 1, 2012 | GlaxoSmithKline |
| NCT01529645 | Phase 1 | Mar 1, 2012 | Ghent University, Novartis |
| NCT01424644 | Phase 4 | Sep 1, 2011 | Novartis |
| NCT01110044 | Phase 2 | Apr 1, 2010 | GlaxoSmithKline |
| NCT01262924 | Phase 3 | Oct 1, 1997 | GlaxoSmithKline |
| NCT01267058 | Phase 3 | Sep 1, 1997 | GlaxoSmithKline |
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 4 | 4 | 2 | 1997 |
| Novartis | For profit | 3 | 3 | 2 | 2011 |
| Radboud University | Academic/Hospital | 2 | 1 | 1 | 2018 |
| University of London | Academic/Hospital | 2 | 2 | 1 | 2018 |
| Adjuvance Technologies, Inc. | For profit | 1 | 1 | 1 | 2021 |
| BioNet-Asia Co., Ltd. | For profit | 1 | 1 | 1 | 2025 |
| Department of Health, United Kingdom | Government | 1 | 0 | 1 | 2019 |
| Free University of Brussels | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Ghent University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Imperial College London | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Leiden University | Academic/Hospital | 1 | 0 | 1 | 2018 |
| National Institute for Public Health and the Environment, RIVM, Holland | Government | 1 | 0 | 1 | 2018 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 1 | 1 | 2018 |
| Thrasher Research Fund | Academic/Hospital | 1 | 0 | 1 | 2019 |
| University of Oxford | Academic/Hospital | 1 | 0 | 1 | 2018 |
| University of Turku | Academic/Hospital | 1 | 0 | 1 | 2018 |
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 |