Prevention of COVID-19
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participant must be >= 18 years of age, at the time of signing the informed consent form (ICF). Male and female Capable of giving signed ICF which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
Exclusion criteria: Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation. Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [AIDS], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy). Individuals considered to have hypersensitivity to any of the study interventions,or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis). Participant has a contraindication to intramuscular(IM) injections or blood draws.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Vaccination Part SARS-CoV-2 neutralizing antibody titer at 28 days following the second vaccination Booster Vaccination Part SARS-CoV-2 neutralizing antibody titer at 28 days following the booster vaccination | — |
Contacts
Shionogi & Co., Ltd.