臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 28, 2024
Last modified on	Aug. 28, 2024
Trial ID	jRCT2031240307

Scientific Title	KD6-287 Phase III Study
Public Title	KD6-287 Phase III Study

Contact for Scientific Queries	Name	Shinmura Yasuhiko
	Affiliation	KM Biologics Co., Ltd.
	Address	1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan
	Telephone	+81-968-37-4073
	E-mail	rinkai-jrct@kmbiologics.com
Contact for Public Queries	Name	Yamashita Masatoshi
	Affiliation	KM Biologics Co., Ltd.
	Address	1314-1 Kyokushi Kawabe, Kikuchi-shi, Kumamoto, Japan
	Telephone	+81-968-37-4073
	E-mail	rinkai-jrct@kmbiologics.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 01, 2024
Actual date of first enrollment
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Healthy infants and children who can receive investigational products three times from 6 to <90 months of age (2) Written informed consent by a legally acceptable representative
	Exclusion Criteria	(1) Has a history of Japanese encephalitis (2) Has a history of immunization against Japanese encephalitis (3) Has a known history of anaphylaxis caused by ingredients of the investigational products (4) Presence of fibrodysplasia ossificans progressiva (5) Has participated in a clinical study and received other investigational products within 4 months (120 days) before the first dose or plans to participate in other clinical study during this study (6) Has received blood transfusion or gamma globulin preparation within 3 months (90 days) before the first dose or massive-dose gamma globulin therapy (>= 200 mg/kg) within 6 months (180 days) before the first dose (7) Has received treatment that may affect the immune function* within 6 months (180 days) before the first dose *Radiotherapy, immunosuppressive drugs (external use is allowed), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone, corticosteroids (>= 2 mg/kg/day of prednisolone equivalent for 14 days or longer, external use is allowed) (8) Is ineligible for other reasons in the investigator (sub-investigator)'s opinion
	Age Minimum	6month old over
	Age Maximum	82month old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of Japanese encephalitis
Intervention(s)		Primary vaccination series: Subcutaneously or intramuscularly inject KD6-287 0.5 mL twice at an interval of 7-28 days (for children below 3 years of age, 0.25 mL per dose) Booster dose: Subcutaneously or intramuscularly inject KD6-287 0.5 mL once >=6 and <15 months after the primary vaccination series (for children below 3 years of age, 0.25 mL per dose).
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Seroconversion rate of neutralizing antibodies after the third dose
Secondary Outcome(s)

Primary Sponsor	KM Biologics Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nihonbashi Sakura Clinic IRB
Address	5F, Inamura Building, 1-9-2, Nihonbashikayabacho, Chuo-ku, Tokyo
Telephone	+81-3-6661-9061
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none