Multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy of COVID-19 vaccine (KD-414(XBB.1.5)) when administered in healthy children aged 6 months to less than 13 years.

JRCT ID: jRCT2071230079

Registered date:04/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 18/11/2023
• Target sample size: 4750
• Study type: Interventional
• Intervention(s): Administer KD-414(XBB.1.5) intramuscularly a dose of 0.5 mL twice at an interval of 28 days

Outcome(s)

Primary Outcome

(Efficacy)
The incidence of COVID-19 during the period of 15 to 105 days after the second dose of the study drug

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 13age old
• Gender: Both

Include criteria

(1) (Japanese) Healthy children aged 6 months to less than 13 years at the time of informed consent
(2) Those whose legally acceptable representatives provide written informed consent

Exclude criteria

(1) Subjects who are infected with novel coronavirus (hereinafter referred to as SARS-CoV-2) or have a history of infection after February 2023 (based on the interview with the legally acceptable representatives)
(2) Subjects who have received a COVID-19 vaccine (including unapproved vaccines) within 6 months (180 days) (However, those received Omicron strain XBB lineage vaccines including unapproved vaccines will be excluded regardless of the timing of vaccination.) (Based on hearing from the representative consenter)
(3) Subjects with a known history of anaphylaxis due to the ingredient (thimerosal) of KD-414 (XBB.1.5)
(4) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before 28 days after the last dose of the study drug, or had menarche who do not agree to use contraceptive method (use of contraceptive devices and drugs, surgery, etc.)
(5) Subjects with fibrodysplasia ossificans progressive
(6) Subjects with a history of Guillain-Barre Syndrome or other demyelinating diseases
(7) Subjects with a history of capillary leak syndrome
(8) Subjects with clinically significant bleeding, or a history of significant bleeding or internal bleeding after intramuscular or intravenous injection
(9) Subjects with a history of thrombocytopenia or venous or arterial thrombosis associated with thrombocytopenia
(10) Subjects with known or suspected immunosuppression or immunodeficiency including asplenia syndrome
(11) Subjects who have participated in any other clinical study and received any other investigational product (excluding placebo) within 4 months (120 days) before the first dose of the study drug, who are planning to participate in any other clinical study during the study period, or who are scheduled to receive a COVID-19 vaccine
(12) Subjects who have received blood transfusion or administration of gamma globulin preparation within 3 months (90 days), or massive dose therapy of gamma globulin preparation (>=200 mg/kg) within 6 months (180 days) before the first dose of the study drug
(13) Subjects who have received any treatment* that may affect the immune function within 6months (180 days) before the first dose of the study drug *Radiotherapy, immunosuppressive drugs (external use is allowed), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone, corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/ day and for >=14days, but external use is allowed)
(14) Subjects with an underlying disease such as cardiovascular disease, renal disease, hepatic disease, hematological disease, developmental disorder, respiratory disease, and diabetes mellitus, whose symptoms are not stable, and who are judged by the investigator or subinvestigator to be difficult to participate in the study
(15) Subjects who are judged by the investigator or subinvestigator to be ineligible as subjects of this study for any other reason

Related Information

• Primary Sponsor: Shinmura Yasuhiko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Ministry of Health, Labour and Welfare