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A Study of TAK-019 in Healthy Japanese Adults (COVID-19)

NCT04712110 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-06-06

Study results available
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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.

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-019 or a placebo in their arm. In this study, a placebo will look like the TAK-019 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-019 than placebo. Participants will receive 2 injections of TAK-019 or placebo, 21 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 attended a clinic visit 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-019 or the placebo.

Conditions

  • Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)

Interventions

BIOLOGICAL

TAK-019

TAK-019 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
2021-02-12
Primary Completion
2022-03-28
Completion
2022-03-28
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 NCT04712110 on ClinicalTrials.gov