Clinical Trial Info

A Study of TAK-919 in Healthy Japanese Adults (COVID-19)

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Staff

The drug being tested in this study is called TAK-919. TAK-919 is being tested to prevent infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2). This study will look at the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults, given 28 days apart.

The study will enroll approximately 200 healthy volunteers. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

TAK-919 0.5 mL

Placebo- this is an injection that looks like the study drug but has no active ingredient

All participants will be asked to take intramuscular injection in the upper arm twice throughout the study.

This multi-center trial will be conducted in Japan. The overall time to participate in this study is 12 months from the second vaccination. Participants will make multiple visits to the clinic and will be contacted by telephone or a final visit after the last vaccination for a follow-up assessment.