A Phase 3 Study to Compare the Immunogenicity against COVID-19, of S-268019 to the ChAdOx1 nCoV-19 vaccine (COVID-19)

Phase 3

• Conditions: Prevention of COVID-19

• Registration Number: JPRN-jRCT2051210151
• Lead Sponsor: agata Tsutae

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified