臨床研究等提出・公開システム

Multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy of COVID-19 vaccine (KD-414 (XBB.1.5) or KD-414 (JN.1)) when administered in healthy children aged 6 months to less than 13 years.

Multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy of COVID-19 vaccine (KD-414 (XBB.1.5) or KD-414 (JN.1)) when administered in healthy children aged 6 months to less than 13 years.

Horita Akira

KM Biologics Co., Ltd.

1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan

rinkai-jrct@kmbiologics.com

Otsuka Kota

KM Biologics Co., Ltd.

1-6-1 Okubo, Kita-ku, Kumamoto-shi, Kumamoto, Japan

+81-96-344-1385

kmb-otoiawase@kmbiologics.com

Not Recruiting

Nov. 01, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

(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

[XBB.1.5 part]
(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 who have received Omicron strain XBB.1.5 lineage vaccines including unapproved vaccines will be excluded regardless of the timing of vaccination.) (based on the interview with the legally acceptable representatives)
(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
[JN.1 part B]
(1) Subjects who are or whose family members in the same household are infected with SARS-CoV-2, or subjects who have a history of infection after December 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 who have received Omicron strain XBB.1.5 or JN.1 lineage vaccines including unapproved vaccines for both of them will be excluded regardless of the timing of vaccination.) (based on the interview with the legally acceptable representatives)
(3) to (15) are the same as those in the [XBB.1.5 part].

Both

Prevention of COVID-19

Administer KD-414 (XBB.1.5) or KD-414 (JN.1) intramuscularly a dose of 0.5 mL twice at an interval of 28 days

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

(Efficacy)
- Vaccine efficacy (VE) in the KD-414 group relative to the placebo group in terms of COVID-19 onset from 15 to 105 days after the second dose of the study drug
- Cumulative incidence of COVID-19 during the period from 15 to 105 days after the second dose of the study drug
- VE against severe COVID-19 onset during the period from 15 to 105 days after the second dose of the study drug
- Incidence of severe COVID-19 during the period from 15 to 105 days after the second dose of the study drug
- Cumulative incidence of severe COVID-19 during the period from 15 to 105 days after the second dose of the study drug
- VE against COVID-19 onset during the period from 15 days after the second dose of the study drug until the number of subjects with COVID-19 onset estimated based on the hypothesis is accumulated
- Incidence of COVID-19 during the period from 15 days after the second dose of the study drug until the number of subjects with COVID-19 onset estimated based on the hypothesis is accumulated
- Cumulative incidence of COVID-19 during the period from 15 days after the second dose of the study drug until the number of subjects with COVID-19 onset estimated based on the hypothesis is accumulated
- VE against severe COVID-19 onset during the period from 15 days after the second dose of the study drug until the number of subjects with COVID-19 onset estimated based on the hypothesis is accumulated
- Incidence of severe COVID-19 during the period from 15 days after the second dose of the study drug until the number of subjects with COVID-19 onset estimated based on the hypothesis is accumulated
- Cumulative incidence of severe COVID-19 during the period from 15 days after the second dose of the study drug until the number of subjects with COVID-19 onset estimated based on the hypothesis is accumulated

+81-92-753-8930

Oct. 26, 2023

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