A S ingle Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)

Phase 3

• Conditions: Coronavirus Disease (COVID-19)

• Registration Number: JPRN-jRCT2071210141
• Lead Sponsor: Kuriyama Kenji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

MAIN PART:
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the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).

Exclusion Criteria

MAIN PART:
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified