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| Column | Value |
|---|---|
| Trial registration number | NCT05299359 |
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Full text link
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : June 7, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 7, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
2022-03-29 |
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Recruitment status
Last imported at : Nov. 30, 2023, 4 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Sept. 15, 2022, 2 a.m. Source : ClinicalTrials.gov |
inclusion criteria: main part: healthy japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent. participant who completed 2 doses primary vaccinations with another specified mrna vaccine which is available in japan 6 to 12 months prior to the trial vaccination. extension part: participants who received the first trial vaccination at least 5 months earlier and are currently enrolled in the main part (ie, not have withdrawn or discontinued early). |
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Exclusion criteria
Last imported at : Sept. 15, 2022, 2 a.m. Source : ClinicalTrials.gov |
main part: participants who received any other sars-cov-2 vaccine (except for the specified mrna vaccine) or other experimental novel coronavirus vaccine prior to the trial. participant who received a booster vaccination (i.e. 3rd dose) participants who have close contact of anyone known to have covid-19 within 14 days prior to the trial vaccination. participants who were tested positive for sars-cov-2 prior to the trial. participants who have traveled outside of japan in the 30 days prior to the trial participation. participants with a clinically significant active infection or oral temperature >= 38 degree celsius within 3 days of the intended date of the first single booster vaccination. participants with body mass index (bmi) greater than or equal to 30 kg/m^2 (bmi= weight in kg/ height in meters^2) extension part: participants with a clinically significant active infection or oral temperature >=38 degree celsius within 3 days of the intended date of the second single booster vaccination. |
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Number of arms
Last imported at : Sept. 15, 2022, 2 a.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Takeda |
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Inclusion age min
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
20 |
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Inclusion age max
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : May 8, 2022, 5:30 a.m. Source : ClinicalTrials.gov |
Japan |
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Type of patients
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
150 |
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primary outcome
Last imported at : Sept. 15, 2022, 2 a.m. Source : ClinicalTrials.gov |
Main Part: Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared with that Observed on Day 36 in Participants from the TAK-019-1501 Study;Main Part: Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 29;Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 29;Main Part: Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 29;Main Part: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination;Main Part: Percentage of Participants with SARS-CoV-2 Infection until Day 29;Main Part: Percentage of Participants with Serious Adverse Events (SAE) until Day 29;Main Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination;Main Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the First Single Booster Vaccination |
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Notes
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 30, 2022, 3 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Sept. 15, 2022, 2 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1260, "treatment_name": "Tak-019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |