Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04313244 | Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years | PHASE3 | COMPLETED | 614 | — | — | May 15, 2021 | Jul 19, 2022 | Feb 7, 2024 | 4 | Thailand |
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...