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

JRCT ID: jRCT2051210151

Registered date:13/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 17/01/2022
• Target sample size: 1000
• Study type: Interventional

Intervention(s)

S-268019-b or ChAdOx1 nCoV-19 vaccine (intramuscular injection)
Only the participants who agree to receive the third vaccination will be given a booster vaccination of
S-268019-b.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nagata Tsutae
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare