Drugs / Pertagen
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | Pertagen | pertussis | 2024-07-31 | “BioNet’s pertussis vaccine is licensed under Pertagen® tradename in Asia and has been submitted under VacPertagen name to EMA centralized procedure by BioNet in France.” bionet-asia.com ↗ |
| Filed | Other | Pertagen | pertussis | 2024-07-31 | “The MAA of Pertagen® has also been submitted to the Australian Therapeutic Goods Administration.” bionet-asia.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02946190 | Oct 2016 → Mar 2017 | pertussis | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05193734 | Feb → Aug 2022 | pertussis | University Hospital, Geneva | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06798831 | Feb → Apr 2025 overdue | — | BioNet-Asia Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06803524 | May → Jun 2025 | pertussis | Mahidol University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-11-21 | BioNet-Asia Co., Ltd. | Regulatory BioNet Receives Positive CHMP Opinion from EMA for VacPertagen, a Recombinant Vaccine Against Pertussis bionet-asia.com ↗
Receiving a positive CHMP opinion for VacPertagen reflects years of scientific innovation and clinical development through collaborative efforts across continents. |
| 2024-07-31 | BioNet-Asia Co., Ltd. | Regulatory BioNet Recombinant Pertussis Vaccine Submitted to EMA bionet-asia.com ↗
BioNet Europe, the French subsidiary of BioNet, a vaccine manufacturer specializing in the development of genetically engineered vaccines, has announced the submission of a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its monovalent Recombinant Pertussis Vaccine (RPV). |
| 2020-12-05 | BioNet-Asia Co., Ltd. | Results Enhanced post-licensure safety surveillance of a new recombinant acellular pertussis vaccine licensed as a monovalent (aP, Pertagen®) and tetanus, reduced-dose diphtheria combination (TdaP, Boostagen®) vaccine for immunization of adolescents and adults in Thailand bionet-asia.com ↗
There were no vaccine-related serious adverse events reported during the surveillance period. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-21 | BioNet-Asia Co., Ltd. | BioNet Receives Positive CHMP Opinion from EMA for VacPertagen, a Recombinant Vaccine Against Pertussis bionet-asia.com ↗ |
| 2024-07-31 | BioNet-Asia Co., Ltd. | BioNet Recombinant Pertussis Vaccine Submitted to EMA bionet-asia.com ↗ |
| 2020-12-05 | BioNet-Asia Co., Ltd. | Enhanced post-licensure safety surveillance of a new recombinant acellular pertussis vaccine licensed as a monovalent (aP, Pertagen®) and tetanus, reduced-dose diphtheria combination (TdaP, Boostagen®) vaccine for immunization of adolescents and adults in Thailand bionet-asia.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pertagen | “This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate...” NCT06798831 ↗ |
| Known as | BioNet recombinant acellular pertussis (aP) vaccine | “This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate...” NCT06798831 ↗ |
| Modality | Vaccine | “The BioNet-Asia study vaccine (Pertagen®)” NCT02946190 ↗ |
| Route | Intramuscular | “All vaccines are presented in 0.5 mL pre-filled syringes to be administered by intramuscular injection.” NCT02946190 ↗ |