Multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the immunogenicity and safety of COVID-19 vaccine (KD-414) when administered in healthy children aged 6 months to less than 12 years.

JRCT ID: jRCT2031220598

Registered date:31/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: The prevention of COVID-19
• Date of first enrollment: 31/01/2023
• Target sample size: 540
• Study type: Interventional
• Intervention(s): Administer KD-414 intramuscularly a dose of 0.5 mL twice at an interval of 28 days.

Outcome(s)

Primary Outcome

[Immunogenicity]
-Geometric mean of neutralizing antibody titers against SARS-CoV-2 (D614) pseudovirus at 28 days after the second dose of the study drug
-Seroconversion rate of neutralizing antibodies against SARS-CoV-2 (D614) pseudovirus at 28 days after the second dose of the study drug
[Safety]
-The incidence of any AEs, AEs resulting in death, serious adverse events (SAEs) other than death, significant AEs, and severe (Grade >= 3) AEs occurring during the period after the first dose of the study drug to the tests after the second dose of the study drug and causal relationship with study drug
-Incidence of AEs resulting in death and SAEs other than deaths occurring during the period from the tests after the second dose of the study drug to the completion of follow-up and causal relationship with study drug
-Incidence, severity, time to onset, duration, incidence by the number of doses, and causal relationship with study drug for specific local AEs
-Incidence, severity, time to onset, duration, incidence by the number of doses, and causal relationship with study drug for specific systemic AEs
-Incidence, severity, time to onset, duration, incidence by the number of doses, and causal relationship with study drug for non-specific AEs
-Maximum body temperature during the period from after each administration of the study drug to 6 days after administration

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 12age old
• Gender: Both

Include criteria

(1) (Japanese) Healthy children aged 6 months to less than 12 years at the time of informed consent
(2) Those whose legally acceptable representatives provide written informed consent

Exclude criteria

(1) Those who are infected with novel coronavirus (hereinafter referred to as SARS-CoV-2) or have a history of infection (based on the interview with the legally acceptable representatives; however, those with a history of infection may be included in Cohort 2)
(2) Those who were judged to be close contact with SARS-CoV-2-infected persons within 14 days (excluding persons whose infection was ruled out by tests) (based on the interview with the legally acceptable representatives; however, those with a history of infection may be included in Cohort 2)
(3) Subjects who have received a COVID-19 vaccine (including unapproved vaccines) in the past
(4) Subjects with a known history of anaphylaxis due to the ingredient of KD-414 (thimerosal)
(5) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before completion of the test 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.)
(6) Subjects with fibrodysplasia ossificans progressiva
(7) Subject with a history of Guillain-Barre Syndrome or other demyelinating diseases
(8) Subjects with a history of capillary leak syndrome
(9) Subjects with clinically significant bleeding, or a history of significant bleeding or internal bleeding after intramuscular or intravenous injection
(10) Subjects with a history of thrombocytopenia or venous or arterial thrombosis associated with thrombocytopenia
(11) Subjects with known or suspected immunosuppression or immunodeficiency including asplenic syndrome
(12) 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
(13) 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
(14) Subjects who have received any treatment* that may affect the immune function within 6 months (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 >= 14 days, but external use is allowed)
(15) 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
(16) 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