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

NCT04677660 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-05-03

Study results available
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Summary

TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919.

At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-919 or a placebo in their arm. In this study, a placebo will look like the TAK-919 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-919 than placebo. Participants will receive 2 injections of TAK-919 or placebo, 28 days apart.

Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection.

During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have visited their clinic 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.

The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-919 or the placebo.

Conditions

  • Coronavirus Disease (COVID-19)

Interventions

BIOLOGICAL

TAK-919

TAK-919 intramuscular injection

BIOLOGICAL

Placebo

Placebo intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2022-02-22
Completion
2022-02-22
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677660 on ClinicalTrials.gov