COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04712110

Takeda Study Registration Call Center

medinfoUS@takeda.com

2021-01-15

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: healthy japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent. participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.

participants who received any other sars-cov-2 or other experimental novel coronavirus vaccine prior to the trial. participants who have close contact of anyone known to have covid-19 within 30 days prior to the trial vaccination. participants who were tested positive for sars-cov-2 prior to the trial or before the trial vaccination. participants who are on current treatment with other investigational agents for prophylaxis of covid-19. participants who have traveled outside of japan in the 30 days prior to the trial participation. participants with a clinically significant active infection (as assessed by the investigator) or oral temperature >= 38 degree celsius within 3 days of the intended date of vaccination. participants with known hypersensitivity or allergy to any of the investigational vaccine components. participants with history or 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. participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease. abnormalities of splenic or thymic function. participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). participants with body mass index (bmi) greater than or equal to 30 kg/m^2 (bmi= weight in kg/ height in meters^2). participants participating in any clinical trial with another investigational product within 30 days prior to the trial vaccination or intend to participate in another clinical trial at any time during the conduct of this trial. participants who received or plan to receive any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration. participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination. participants involved in the trial conduct or their first degree relatives. participants who have history or infection of hepatitis b, hepatitis c, and human immunodeficiency virus infection. female participants who are pregnant or breastfeeding.

2

Takeda

20

100

Japan

Healthy volunteers

N/A

200

Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36;Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36;Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50;Percentage of Participants With Any AE Leading to Discontinuation of Vaccination;Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50;Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50;Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50;Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50;Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination;Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination;Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination;Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination;Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination;Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination;Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36;Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1260, "treatment_name": "Tak-019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]