臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 18, 2022
Last modified on	Aug. 23, 2024
Trial ID	jRCT2031210679

Scientific Title	A Phase 3, Randomized, Double-Blind, Active-Controlled, Confirmatory Study to Compare the Immunogenicity, Efficacy, and Safety of KD-414 Vaccine and Vaxzevria Vaccine in Adults Aged 18 to 40 Years Old (COVID-19) (kd414-03)
Public Title	A Phase 3, Randomized, Double-Blind, Active-Controlled, Confirmatory Study to Compare the Immunogenicity, Efficacy, and Safety of KD-414 Vaccine and Vaxzevria Vaccine in Adults Aged 18 to 40 Years Old (COVID-19) (kd414-03)

Contact for Scientific Queries	Name	Fushimi Hideki
	Affiliation	Meiji Seika Pharma Co.,Ltd.
	Address	2-4-16, Kyobashi, Chuo-ku, Tokyo
	Telephone	+81-3-3273-3745
	E-mail	clinical-trials@meiji.com
Contact for Public Queries	Name	Clinical Development Dept.
	Affiliation	Meiji Seika Pharma Co., Ltd.
	Address	2-4-16, Kyobashi, Chuo-ku, Tokyo
	Telephone	+81-3-3273-3745
	E-mail	clinical-trials@meiji.com

Recruitment status	Complete

Anticipated date of first enrollment		April. 27, 2022
Actual date of first enrollment		April. 30, 2022
Target sample size		1500
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. Is capable of understanding the written informed consent, provides signed informed consent, and agrees to comply with protocol requirements. 2. Is aged 18 to 40 years old. 3. Is healthy or medically stable as determined by investigator judgment based on medical history, physical examination, and vital signs. Medically stable condition is defined as any chronic medical disease or condition that has not required a change in medication or surgical intervention or resulted in hospitalization or medically attended events within 6 months prior to screening.
	Exclusion Criteria	1. Has a current diagnosis or a history of laboratory confirmed SARS-CoV-2. 2. Has close contacts with person(s) with COVID-19 within 14 days of the first dose of study vaccine (based on the interview with subject). 3. Has been infected with HIV.. 4. Has received any prior vaccines against COVID-19. 5. Has experienced documented anaphylaxis caused by an ingredient of study vaccine.
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of COVID-19 infection
Intervention(s)		KD-414 is an inactivated whole-particle vaccine containing purified inactivated SARS CoV 2 cultured in Vero cells derived from African green monkey kidney cells, with aluminum hydroxide as adjuvant. Each KD-414 vaccine contains inactivated SARS-CoV-2 and excipients. Subjects randomly assigned to receive KD-414 will be vaccinated on Days 1, 29, and 120. The vaccine will be administered by IM injection into the deltoid muscle. Vaxzevria vaccine is a monovalent vaccine composed of a single recombinant, replication deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. Vaxzevria vaccine contains recombinant ChAdOx1-S. Subjects randomly assigned to receive Vaxzevria will be vaccinated on Days 1 and 29. On Day 120, normal saline will be administered. The vaccine and normal saline will be administered by IM injection into the deltoid muscle.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Geometric mean titer of serum neutralizing antibody against SARS-CoV-2 at 28 days after the third dose of KD-414 (Day 148) as compared with that at 28 days after the second dose of Vaxzevria (Day 57).
Secondary Outcome(s)

Primary Sponsor	Meiji Seika Pharma Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	AMED
Secondary Sponsor	Not applicable

Source of Monetary Support	MHLW
Secondary Sponsor	Not applicable

Name of Certified Review Board	Medical Corporation Adachi Kyosai Hospital Institutional Review Board
Address	1-36-8, Yanagihara, Adachi-ku, Tokyo
Telephone	+81-3-3881-6116
E-Mail	hashimoto.emiko@neues.co.jp
Approval Status	Approval
Date of approval	April. 21, 2022

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-6665-0572
E-Mail	secretariat@hurecs.org
Approval Status	Approval
Date of approval	April. 21, 2022

Name of Certified Review Board	Hakodate Central General Hospital Institutional Review Board
Address	33-2, Honcho, Hakodate-shi, Tokyo
Telephone	+81-138-52-1231
E-Mail	somuka@hakochu-hp.gr.jp
Approval Status	Approval
Date of approval	April. 21, 2022

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	April. 21, 2022

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Tokyo
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	April. 21, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	Philippines

History of Changes

No	Publication date
5	Aug. 23, 2024	(this page)	Changes
4	Aug. 11, 2022	Detail	Changes
3	July. 14, 2022	Detail	Changes
2	April. 22, 2022	Detail	Changes
1	Mar. 18, 2022	Detail

List of change history