Prevention of SARS-CoV-2 infection SARS-CoV-2, COVID-19
Conditions
Interventions
CSL402: Administer 0.5 mL (5 micro g) as a single intramuscular injection.
Sponsors
Minamida Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects (irrespective of gender) must be healthy and >=12 years 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 or SPIKEVAX) and satisfy the following criteria: (a) Received 2 doses of an authorized mRNA COVID-19 vaccine (monovalent: Wuhan strain) 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, etc.
Exclusion criteria
Exclusion criteria: (1) Individuals with acute medical illness or fever of >= 37.5 degree celcius 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 JN.1) on Day 29 | — |
Contacts
Public ContactClinical Development Dept.
Meiji Seika Pharma Co.,Ltd.
Outcome results
None listed