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Mar. 18, 2022

Aug. 11, 2022

jRCT2031210679

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)

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)

Fushimi Hideki

Meiji Seika Pharma Co.,Ltd.

2-4-16, Kyobashi, Chuo-ku, Tokyo

+81-3-3273-3745

clinical-trials@meiji.com

Clinical Development Dept.

Meiji Seika Pharma Co., Ltd.

2-4-16, Kyobashi, Chuo-ku, Tokyo

+81-3-3273-3745

clinical-trials@meiji.com

Not Recruiting

April. 27, 2022

April. 30, 2022
1500

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

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.

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.

18age old over
40age old under

Both

Prevention of COVID-19 infection

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.

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).

Meiji Seika Pharma Co., Ltd.
AMED
Not applicable
MHLW
Not applicable
Medical Corporation Adachi Kyosai Hospital Institutional Review Board
1-36-8, Yanagihara, Adachi-ku, Tokyo

+81-3-3881-6116

hashimoto.emiko@neues.co.jp
Approval

Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
2-2-1, Kyobashi, Chuo-ku, Tokyo

+81-3-6665-0572

secretariat@hurecs.org
Approval

Hakodate Central General Hospital Institutional Review Board
33-2, Honcho, Hakodate-shi, Tokyo

+81-138-52-1231

somuka@hakochu-hp.gr.jp
Approval

Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo

+81-3-5366-3006

scl-irb@shinanokai.com
Approval

Medical Corporation Heishinkai OPHAC Hospital IRB
4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Tokyo

+81-6-6395-9000

ophach_irb@heishinkai.com
Approval

No

Philippines

History of Changes

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