SOUSEIKAI Global Clinical Research Center has a long and successful history conducting vaccine studies.
We have conducted 36 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 cancer, 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 11 government research 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.
- A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults.
Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5.
- Safety, tolerability, and immunogenicity of a novel 4-antigen Staphylococcus aureus vaccine (SA4Ag) in healthy Japanese adults.
Hum Vaccin Immunother. 2018;14(11):2682-2691. doi: 10.1080/21645515.2018.1496764. Epub 2018 Aug 17.
- Prior vaccinations improve immunogenicity of inactivated influenza vaccine in young children aged 6 months to 3 years: A cohort study.
Medicine (Baltimore). 2018 Jul;97(29):e11551. doi: 10.1097/MD.0000000000011551.
- Safety, tolerability and immunogenicity of the ExPEC4V (JNJ-63871860) vaccine for prevention of invasive extraintestinal pathogenic Escherichia coli disease: A phase 1, randomized, double-blind, placebo-controlled study in healthy Japanese participants.
Hum Vaccin Immunother. 2018;14(9):2150-2157. doi: 10.1080/21645515.2018.1474316. Epub 2018 Jun 28.
- Protective Effect of Maternal Influenza Vaccination on Influenza in Their Infants: A Prospective Cohort Study.
J Infect Dis. 2018 Mar 5;217(6):878-886. doi: 10.1093/infdis/jix629.
- 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 1,500 healthy young and 650 Elderly subjects per study.
Examples of Vaccine Studies: Polio Chikenpox, Flu, RSV, Pneumonia, Clostridium difficille, Zoster