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Aug. 10, 2022

July. 21, 2023

jRCT2031220264

A Phase 3, Randomized, Active-Comparator, Observer-Blind, Non-Inferiority Study of DS-5670a (COVID-19 Vaccine) in Adults Aged 18 Years and Older

A Phase 3, Randomized, Active-Comparator, Observer-Blind, Non-Inferiority Study of DS-5670a in Adults Aged 18 Years and Older

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Complete

Sept. 01, 2022

Sept. 01, 2022
420

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

1)Healthy adults >= 18 years of age at the time of consent
2)Has signed and dated a written informed consent form (ICF).
3)With no history of vaccination against SARS-CoV-2.
4)Willing and able to comply with all scheduled requirements (including medical examinations, laboratory tests), and report any symptoms.

1)Known medical history of convulsion or seizure epilepsy due to vaccination.
2)Known medical history of myocarditis or underlying condition of myocarditis.
3)Has been diagnosed with SARS-CoV-2 infection by (RT-PCR test, SARS-CoV-2 antigen test, or SARS-CoV-2 antibody test in the past.
4)Has suggestive symptoms of SARS-CoV-2 infection (respiratory symptoms, headache, malaise, olfactory disturbance, taste disturbance, pharyngalgia etc.) at the time of consent.
5)Has a positive result on the screening for SARS-CoV-2 infection (antigen test or antibody test) at the confirmation of eligibility.
6)Known medical history of immediate systemic allergic reactions such as anaphylaxis, angioedema, or severe allergy to food, pharmaceuticals, cosmetics, vaccines, etc.

18age old over
No limit

Both

Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)

A intramuscular injection of DS-5670a or Comirnaty twice in total

Geometric mean titer (GMT) and seroconversion rate of serum neutralizing activity against SARS-CoV-2 4 weeks after the second dose of the study drug (Day 57)

Efficacy:
- Geometric mean fold rise (GMFR) of serum neutralizing activity against SARS-CoV-2 4 weeks after the second dose of the study drug (Day 57)
- The incidence of SARS-CoV-2 infection within 52 weeks from the administration of study drug (Day 393)
Safety:
- Solicited adverse events (injection site and systemic)
- Unsolicited adverse events
- Serious adverse events
- Laboratory test results

DAIICHI SANKYO Co.,Ltd.
Ministry of Health, Labour and Welfare
Not applicable
Tokushukai Group Institutional Review Board
1-8-7, Koji-machi, Chiyoda-ku, Tokyo

+81-3-3263-4801

irb@mirai-iryo.com
Approval

No

none

History of Changes

No Publication date
5 July. 21, 2023 (this page) Changes
4 Dec. 02, 2022 Detail Changes
3 Oct. 07, 2022 Detail Changes
2 Sept. 12, 2022 Detail Changes
1 Aug. 10, 2022 Detail