Prevention of SARS-CoV-2 infection SARS-CoV-2, COVID-19
Conditions
Interventions
Cohort A
Child group: Vaccinate subjects with a single intramuscular dose of 0.1 mL (1.0 microgram) or 0.25 mL (2.5 microgram).
Adult group: Vaccinate subjects with a single intramuscular dose of 0.5
Sponsors
Minamida Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects (irrespective of gender) must be healthy and >= 12 of age at screening. (2) Subjects must freely provide documented informed consent. Children who are younger than 18 years of age must have the written consent of a legally acceptable representative and must personally consent using a consent form or assent form. (3) Subjects must have received at least 2 doses of an authorized mRNA COVID-19 vaccine (COMIRNATY, SPIKEVAX or DAICHIRONA) and satisfy the following criteria: (a) Received 2 doses of an authorized mRNA COVID-19 vaccine as initial immunization (b) At the time of screening, at least 3 months have passed since the last vaccination (c) Receipt of these vaccines is supported by documentation
Exclusion criteria
Exclusion criteria: (1) Individuals with acute medical illness or fever of >= 37.5 degrees Celsius within 1 day prior to screening. These individuals may be offered the opportunity to enter the study after fever and illness have resolved. (2) Individuals with a positive SARS-CoV-2 antigen test at screening or confirmed SARS-CoV-2 infection in a family member with whom they live. (3) Individuals with a confirmed SARS-CoV-2 infection or history of COVID-19 with ongoing sequelae within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT) of neutralizing antibodies against SARS-CoV-2 (Omicron XEC) on Day 29 | — |
Contacts
Public ContactClinical Development Dept.
Meiji Seika Pharma Co.,Ltd.
Outcome results
None listed