A Phase 2/3 Study of S-268019 (COVID-19)

Phase 2

• Conditions: Prevention of COVID-19

• Registration Number: JPRN-jRCT2031210383
• Lead Sponsor: agata Tsutae

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3100

Inclusion Criteria

Participant must be >= 20 years of age inclusive, at the time of signing the informed consent.
Male and female
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria

Positive SARS-CoV-2 antigen test result at Screening.
Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy
Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs within 6 months prior to the first dose of study intervention, being treated for malignancy or receiving other immunosuppressive therapy].
Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).
Participant has a contraindication to IM injections or blood draws. et, al.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events/adverse reactions/serious adverse events/solicited adverse events/medically attended adverse events/adverse event of special interest.<br>SARS-CoV-2 neutralizing antibody titer on Day 239