A Booster Study of S-268023 (COVID-19)

JRCT ID: jRCT2031230503

Registered date:11/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 16/12/2023
• Target sample size: 600
• Study type: Interventional
• Intervention(s): Intramuscular injection of S-268023 or COMIRNATY RTU intramuscular injection (XBB.1.5 variant)

Outcome(s)

Primary Outcome

SARS-CoV-2 neutralizing antibody titer on day 29 (XBB.1.5 variant)
-GMT
-Seroresponse rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants aged 20 years or older, at the time of sigining the informed consent form.
-Participants who have passed 90 days or more after completing the primary vaccination or booster vaccination with an approved SARS-CoV-2 vaccine (excluding an approved monovalent XBB.1.5 SARS-CoV-2 vaccine).
-Participants with no infection history of SARS-CoV-2, or participants with infection history of SARS-CoV-2 who have not been infected since March 2023.
-Male and female.

Exclude criteria

-Participants who have previously received an approved monovalent XBB.1.5 SARS-CoV-2 vaccines.
-Participants who tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.

Related Information

• Primary Sponsor: Gomez Juan Carlos
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare