COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04677660

Takeda Study Registration Call Center

medicalinformation@tpna.com

2020-12-21

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: healthy japanese male and female participants. 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 vaccine administration. participants who were tested positive for sars-cov-2 prior to the trial or on the test before the vaccination. participants who are on current treatment with other investigational agents for prophylaxis of covid 19. participants who 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 vaccination. participants with a known hypersensitivity or allergy to any of the imp components. 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. 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 bmi >= 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 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 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 are with or have history of hepatitis b and hepatitis c infection, or with known human immunodeficiency virus (hiv) infection or hiv-related disease.. female participants who are pregnant or breastfeeding.

2

Takeda

20

100

Japan

Healthy volunteers

N/A

200

Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57;Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57;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 57;Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57;Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57;Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57;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 28 Days Following First Vaccination;Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination;Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]