Phase 2 study of BK1901 as a Booster in Japanese children

Fuji Hideyuki0 个研究点目标入组 200 人开始时间: 2021年3月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Japanese healthy children aged 5 to less than 7 years old on the day of injection.
•2. Subjects who has written informed consent from legal guardian and has obtained an assent from subject.
•3. Subjects are able to comply with the study procedures.
•4. Subjects who had been vaccinated 3 or 4 times DPT-IPV with the same products at <30 months old and have not been vaccinated DPT-IPV since then.

•1. Subjects who had history of diphtheria, pertussis, tetanus or acute poliomyelitis.
•2. Subjects who had history of diphteria, pertussis, tetanus or polio vaccination except DPT-IPV.
•3. Subjects who had history of COVID-19.
•4. Subjects who had history of anaphylaxis to the components of the study drug.
•5. Subjects who had histories of cardiovascular disease, blood system, liver, kidney, digestive system, metabolism, neuropsychiatric disease.
•6. Subjects who have a current history of apparent immunologic disorder and/or under immunosuppressive therapy.
•7. Subjects who received blood transfusion and/or gamma globulin preparation from Day-90 or less, and/or received high-dose therapy (200mg/kg or more) of gamma globulin preparation from Day-180 or less prior to study administration.
•8. Subjects who have received other investigational products from Day-120 or less prior to study administration.
•9. Subjects who have been considered to be not eligible by the principal investigators (sub-investigators) for the enrollment.

发起方

Fuji Hideyuki