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

JRCT ID: jRCT2031220264

Registered date:10/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
• Date of first enrollment: 01/09/2022
• Target sample size: 420
• Study type: Interventional
• Intervention(s): A intramuscular injection of DS-5670a or Comirnaty twice in total

Outcome(s)

• Primary Outcome: 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)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare