Trial at a glance
What medical condition is being studied? Prevention of Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
What is the trial testing? TAK-919, Placebo
Are placebos part of the trial? Yes
How many participants are being enrolled? 200
When is the trial being conducted? -
How long is participation in the trial? This study will take place in Japan. Each participant will be in the study for up to 394 days (just over 12 months). This will include the time for the 2 injections. Participants will visit the clinic 7 times. There might be more clinic visits for extra nose swabs if required.
Key requirements
Sex
All
Age
From 20 Years
Accepts Healthy Volunteers?
Trial Details / Participation Requirements
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Trial Phase: Phase 1/Phase 2
Trial Type: Interventional
Trial Arms/Groups or Cohorts:
TAK-919: TAK-919 0.5 mL, intramuscular injection in the upper arm
Placebo: TAK-919 Matching Placebo, intramuscular injection in the upper arm
Intervention: TAK-919, Placebo
Primary Outcome Measure(s):
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]
Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination [Time Frame: Up to Day 7 after each vaccination]
Percentage of Participants with Unsolicited AEs for 28 Days After Each Vaccination [Time Frame: Up to Day 28 after each vaccination]
Percentage of Participants with Serious AE (SAE) until Day 57 [Time Frame: Up to Day 57]
Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 57 [Time Frame: Up to Day 57]
Percentage of Participants with Any AE Leading to Discontinuation of Vaccination [Time Frame: Up to Day 57 (up to discontinuation of vaccination)]
Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 57 [Time Frame: Up to Day 57]
Percentage of Participants with SARS-CoV-2 Infection until Day 57 [Time Frame: Up to Day 57]
Geometric Mean Titers (GMT) of Serum binding antibody (bAb) Against SARS-CoV-2 on Day 57 [Time Frame: Day 57]
Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 [Time Frame: Day 57]
Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 [Time Frame: Day 57]
Secondary Outcome Measure(s):
Percentage of Participants with SAE throughout the Trial [Time Frame: Up to Day 394]
Percentage of Participants with MAAEs throughout the Trial [Time Frame: Up to Day 394]
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]
Percentage of Participants with SARS-CoV-2 Infection throughout the Trial [Time Frame: Up to Day 394]
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]
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]
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]
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]
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]
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]
Entry Criteria:
- Must be healthy Japanese men or women aged 20 years or older.
- If men could conceive children or women could become pregnant, they must be willing to use birth control from when they join the study until 3 months after the 2nd injection.
- Cannot have received any other vaccine to prevent Covid-19.
- Cannot have been in close contact with anyone who has COVID-19 in the last 30 days.
- Cannot have previously tested positive for Covid-19.
- Cannot have traveled outside of Japan in the last 30 days.
- Cannot have an infection that the study doctor thinks is medically important.
- Cannot have any known reactions to any component of the vaccine.
- Cannot have an immune system that is not working properly.
- Cannot have received any blood or plasma products in the last 3 months.
- Women cannot be pregnant or be breastfeeding.
Trial Locations
RESULTS
Sumida Hospital
Japan, 〒130-0004 Tōkyō-to, Sumida City, Honjo, 1-chōme−29−1 ランダムスクウエア本所ビル
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PS Clinic
Japan, 〒810-0005 Fukuoka, 福岡市中央区Chūō-ku, Kiyokawa, 1-chōme−9, −20 テングッッド 渡辺 通 3 階
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Trial Protocol ID: TAK-919-1501
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