Status:
COMPLETED
A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Lead Sponsor:
Takeda
Conditions:
Coronavirus Disease (COVID-19)
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019 f...
Eligibility Criteria
Inclusion
- 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the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).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
- 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.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05299359
Start Date
April 15 2022
End Date
October 18 2023
Last Update
October 21 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sumida Hospital
Sumida-ku, Tokyo, Japan
2
PS Clinic
Fukuoka, Japan