SOUSEIKAI Global Clinical Research Center has a long and successful history conducting vaccine studies.
We have conducted 30 clinical trials since 2005 in all phases (Phase 1 ~ Phase 4), and the subjects of these trials covered not only healthy young adults, but also adolescents, the healthy elderly, and vaccination cases that require special attention, including patients with Diabetes Mellitus or Rheumatoid arthritis. We also have an on-going research grant from the Ministry of Health, Labor, and Welfare of Japan.
Currently we have conducted 10 protocols of vaccine studies in children under 4 years old, adults, the elderly, and also in patients under immunosuppressant therapies. Our mission is in challenging the bigger goal of providing the benefits of vaccinations to people all over the world.
- Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine when administered to healthy Japanese adults aged ≥50 years. An open-label trial.
Hum Vaccin Immunother. 2014 Jul;10(7):1850-8. doi: 10.4161/hv.28633
- Immunogenicity of the trivalent inactivated influenza vaccine in young children less than 4 years of age, with a focus on age and baseline antibodies.
Clin Vaccine Immunol. 2014 Sep;21(9):1253-60. doi: 10.1128/CVI.00200-14. Epub 2014 Jul 2
- Pharmacogenomic/pharmacokinetic assessment of a four-probe cocktail for CYPs and OATPs following oral microdosing.
Int J Clin Pharmacol Ther. 2012 Oct;50(10):689-700. doi: 10.5414/CP201763.
You can choose the location and number of CRUs in our SOUSEIKAI Global Clinical Research Center depending on the needs of your study.
We have experience in conducting vaccine studies safely and efficiently with up to 800 subjects per study.