Prevention of COVID-19 infection
Conditions
Interventions
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. E
Sponsors
Fushimi Hideki
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan, Philippines
Contacts
Public ContactClinical Development Dept.
Meiji Seika Pharma Co., Ltd.
Outcome results
None listed