A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Coronavirus Disease (COVID-19)
About this trial
This is an interventional prevention trial for Coronavirus Disease (COVID-19)
Eligibility Criteria
Inclusion Criteria:
MAIN PART:
- Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent.
Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine which is available in Japan 6 to 12 months prior to the trial vaccination.
EXTENSION PART:
- 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the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).
Exclusion Criteria:
MAIN PART:
- 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.
- Participant who received a booster vaccination (i.e. 3rd dose)
- Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.
- Participants who were tested positive for SARS-CoV-2 prior to the trial.
- Participants who have traveled outside of Japan in the 30 days prior to the trial participation.
- 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.
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:
- 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.
Sites / Locations
- Sumida Hospital
- PS Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TAK-019 Main Part
TAK-019 Extension Part
TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm
TAK-019 0 .5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm. The participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will receive a second single booster vaccination of TAK-019 by intramuscular injection.