A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)

Kuriyama Kenji0 个研究点目标入组 150 人开始时间: 2022年3月30日最近更新: 2024年1月22日

试验速览

暂无简介。

•1.Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
•2.Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine (SARS-CoV-2) which is available in Japan 6 to 12 months prior to the trial vaccination.
•EXTENSION PART:
•3.Participants who received the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).

•1.Participants who received any other SARS-CoV-2 vaccine (except for the specified mRNA vaccine) or other experimental novel coronavirus vaccine prior to the trial.
•2.Participant who received a booster vaccination (i.e. 3rd dose)
•3.Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.
•4.Participants who were tested positive for SARS-CoV-2 prior to the trial.
•5.Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
•6.Participants with a clinically significant active infection or oral temperature >= 38 degree Celsius within 3 days of the intended date of the first single booster vaccination.
•7.Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2).
•EXTENSION PART:
•8.Participants with a clinically significant active infection or oral temperature >=38 degree Celsius within 3 days of the intended date of the second single booster vaccination.

发起方

Kuriyama Kenji