Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
Conditions
Sponsors
Inoguchi Akihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed