drugset / Trial / NCT04313244
Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone.
Timeline
- Start
- 2021-05-15
- Primary completion
- 2022-02-21
- Completion
- 2022-07-19
Publications
- El Hindi T, Anugulruengkitt S, Lapphra K, Limkittikul K, Tangsathapornpong A, Galindo CM, Hellwig M, Roubinis N, Schuring R, Biswal S, Folschweiller N. Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine. Vaccine. 2025 Oct 24;65:127786. doi: 10.1016/j.vaccine.2025.127786. Epub 2025 Oct 6.
- El Hindi T, Anugulruengkitt S, Lapphra K, Limkittikul K, Tangsathapornpong A, Galindo-Tsoukas C, Hellwig M, Roubinis N, Schuring R, Biswal S, Folschweiller N. Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine. Vaccine. 2025 Aug 30;62:127558. doi: 10.1016/j.vaccine.2025.127558. Epub 2025 Jul 31.
- Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DENGUE VIRUS, LIVE ATTENUATED | Vaccine | 0.5 ml | Subcutaneous |
| Subject | Gardasil 9 | Vaccine | 0.5 ml | Intramuscular |