COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071210141

Trial Information Contact for Clinical

smb.Japanclinicalstudydisclosure@takeda.com

2022-03-30

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

unclear

Prevention

1.Healthy Japanese male and female adult subjects aged >= 20 years of age at the time of signing of informed consent.2.Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine (SARS-CoV-2) which is available in Japan 6 to 12 months prior to the trial vaccination.

1.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.2.Participant who received a booster vaccination (i.e. 3rd dose) 3.Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination.4.Participants who were tested positive for SARS-CoV-2 prior to the trial.5.Participants who have traveled outside of Japan in the 30 days prior to the trial participation.6.Participants with a clinically significant active infection or oral temperature >= 38 degree Celsius within 3 days of the intended date of vaccination.7.Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2).

1

Kuriyama Kenji

20

100

Japan

Healthy volunteers

N/A

150

1.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 StudyTime Frame: Day 15GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in subjects from the TAK-019-1501 study (NCT04712110) will be reported.2.Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Booster VaccinationTime Frame: 7 days after booster vaccinationAE is defined as any untoward medical occurrence in a clinical investigation subject administered an investigational medicinal product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs are defined as injection site pain; tenderness; erythema/redness; induration; and swelling.3.Percentage of Participants with Solicited Systemic AEs for 7 Days Following Booster VaccinationTime Frame: 7 days after booster vaccinationSolicited systemic AEs are defined as fever; fatigue; malaise; myalgia; arthralgia; nausea/vomiting; and headache.4.Percentage of Participants with Unsolicited AEs for 28 Days Following Booster VaccinationTime Frame: 28 days after booster vaccinationUnsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.5.Percentage of Participants with Serious Adverse Events (SAE) until Day 29Time Frame: Up to Day 29An SAE is defined as any untoward medical occurrence that: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Leads to a congenital anomaly/birth defect in the offspring of a participant; or Is an important medical event.6.Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 29Time Frame: Up to Day 29An AESI is defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study include the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; Neuroinflammatory Disorders; Musculoskeletal and Connective Tissue Disorders; Vasculitides; Gastrointestinal Disorders; Hepatic Disorders; Renal Disorders; Cardiac Disorders; Skin Disorder; Hematologic Disorders; Metabolic Disorders; and Other Disorders.7.Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 29Time Frame: Up to Day 298.Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 29Time Frame: Up to Day 299.Percentage of Participants with SARS-CoV-2 Infection until Day 29Time Frame: Up to Day 29

Phase 3

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