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9vHPV Vaccine · 1 trial · 1 indication
GMTs for HPV were measured by immunoglobulin G binding assay (IgGBA) assay. HPV-6, HPV-11, HPV-16, HPV-18, HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 were the types of HPV analyzed.
| Arm | Type | Description |
|---|---|---|
| 9vHPV+TDV | EXPERIMENTAL | Participants will receive 0.5 mL 9vHPV intramuscularly (IM) with 0.5 mL TDV subcutaneously (SC) once on Day 1 (Month 0) followed by 0.5 mL TDV SC once on Day 90 (Month 3) and 0.5 mL 9vHPV IM once on Day 180 (Month 6). |
| 9vHPV | EXPERIMENTAL | Participants will receive 0.5 mL 9vHPV vaccine IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV vaccine IM once on Day 180 (Month 6). |
| Name | Type | Description |
|---|---|---|
| 9vHPV Vaccine | BIOLOGICAL | 9vHPV intramuscular injection |
| Dengue Tetravalent Vaccine (TDV) | BIOLOGICAL | TDV subcutaneous injection |
Inclusion Criteria: 1. Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator. 2. Participants who can comply with trial procedures and are available for th...
The 9vHPV vaccine is a recombinant 9-valent human papillomavirus vaccine being studied by Takeda Pharmaceutical Company Limited. It is a vaccine candidate evaluated in a Phase 3 trial in participants aged 9 to under 15 years, in the context of dengue fever research.
The 9vHPV vaccine is not a dengue treatment. It is a recombinant 9-valent human papillomavirus vaccine that was evaluated alongside a dengue tetravalent vaccine in a Phase 3 immunogenicity and safety study in Thailand. The trial enrolled healthy volunteers aged 9 to under 15 years.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of the 9vHPV vaccine candidate. The company sponsored the Phase 3 trial of the vaccine in Thailand.
The 9vHPV vaccine is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are ongoing. The vaccine is investigational and has not been approved by the FDA for any indication.
The 9vHPV vaccine was studied in a single Phase 3 trial, NCT04313244, titled Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged 9 to under 15 Years. The trial enrolled 614 participants in Thailand and is completed.