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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 June 2021 |
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Main ID: |
NCT04677660 |
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Date of registration:
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18/12/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of TAK-919 in Healthy Japanese Adults (COVID-19)
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Scientific title:
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A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19) |
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Date of first enrolment:
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January 21, 2021 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04677660 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Healthy Japanese male and female participants.
2. Participants who understand and are willing to comply with trial procedures and are
available for the duration of follow up.
Exclusion Criteria:
1. Participants who received any other SARS-CoV-2 or other experimental novel coronavirus
vaccine prior to the trial.
2. Participants who have close contact of anyone known to have COVID-19 within 30 days
prior to vaccine administration.
3. Participants who were tested positive for SARS-CoV-2 prior to the trial or on the test
before the vaccination.
4. Participants who are on current treatment with other investigational agents for
prophylaxis of COVID 19.
5. Participants who traveled outside of Japan in the 30 days prior to the trial
participation.
6. Participants with a clinically significant active infection (as assessed by the
Investigator) or oral temperature >= 38 degree Celsius within 3 days of the
vaccination.
7. Participants with a known hypersensitivity or allergy to any of the IMP components.
8. Participants with any illness or history of any illness that, in the opinion of the
Investigator, might interfere with the results of the trial or pose additional risk to
the participants due to participation in the trial.
9. Participants with known or suspected impairment/alteration of immune function,
including history of any autoimmune disease or neuro-inflammatory disease.
10. Abnormalities of splenic or thymic function.
11. Participants with a known bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.
12. Participants with any serious chronic or progressive disease (eg, neoplasm, insulin
dependent diabetes, cardiac, renal, or hepatic disease).
13. Participants with BMI >= 30 kg/m^2 (BMI=weight in kg/height in meters^2).
14. Participants participating in any clinical trial with another investigational product
within 30 days prior to the vaccination or intend to participate in another clinical
trial at any time during the conduct of this trial.
15. Participants who received or plan to receive any other vaccines within 14 days (for
inactivated vaccines) or 28 days (for live vaccines) prior to trial dose
administration.
16. Participants with acute or chronic clinically significant disease including pulmonary,
cardiovascular, hepatic, or renal abnormality evaluated by physical examination.
17. Participants involved in the trial conduct or their first-degree relatives.
18. Participants who are with or have history of hepatitis B and hepatitis C infection, or
with known human immunodeficiency virus (HIV) infection or HIV-related disease..
19. Female participants who are pregnant or breastfeeding.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
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Intervention(s)
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Biological: TAK-919
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Biological: Placebo
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Primary Outcome(s)
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Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57
[Time Frame: Day 57]
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Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57
[Time Frame: Day 57]
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Percentage of Participants with SARS-CoV-2 Infection until Day 57
[Time Frame: Up to Day 57]
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Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination
[Time Frame: Up to Day 28 after each vaccination]
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Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57
[Time Frame: Up to Day 57]
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Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57
[Time Frame: Day 57]
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Percentage of Participants with Any AE Leading to Discontinuation of Vaccination
[Time Frame: Up to Day 57 (up to discontinuation of vaccination)]
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Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination
[Time Frame: Up to Day 7 after each vaccination]
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Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination
[Time Frame: Up to Day 7 after each vaccination]
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Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57
[Time Frame: Up to Day 57]
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Percentage of Participants with Serious AE (SAE) until Day 57
[Time Frame: Up to Day 57]
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Secondary Outcome(s)
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SCR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394
[Time Frame: Day 29, Day 43, Day 57, Day 209, and Day 394]
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GMT of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394
[Time Frame: Day 29, Day 43, Day 209 and Day 394]
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Percentage of Participants with MAAEs throughout the Trial
[Time Frame: Up to Day 394]
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Percentage of Participants with SAE throughout the Trial
[Time Frame: Up to Day 394]
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GMFR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394
[Time Frame: Day 29, Day 43, Day 209 and Day 394]
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SCR of Serum bAb Against SARS-CoV-2 on Day 29, Day 43, Day 209 and Day 394
[Time Frame: Day 29, Day 43, Day 209 and Day 394]
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Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of Vaccination throughout the Trial
[Time Frame: Up to Day 394]
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GMFR of serum nAb against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394
[Time Frame: Day 29, Day 43, Day 57, Day 209, and Day 394]
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GMT of serum neutralizing antibody (nAb) against SARS-CoV-2 on Day 29, Day 43, Day 57, Day 209, and Day 394
[Time Frame: Day 29, Day 43, Day 57, Day 209, and Day 394]
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Percentage of Participants with SARS-CoV-2 Infection throughout the Trial
[Time Frame: Up to Day 394]
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Secondary ID(s)
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jRCT2071200069
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TAK-919-1501
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U1111-1261-9040
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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