A Booster Study of S-268019 in Japan-2 (COVID-19)

JRCT ID: jRCT2031210613

Registered date:17/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 28/02/2022
• Target sample size: 150
• Study type: Interventional

Intervention(s)

One dose of S-268019 via intramuscular injection.
Participants who provided informed consent for the second booster dose will receive one dose of S-268019 again via intramuscular injection.

Outcome(s)

• Primary Outcome: Safety

Key inclusion & exclusion criteria

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

Include criteria

Participant must be >= 20 years of age inclusive, at the time of signing the informed consent.
Participant who have received 2 doses of SARS-CoV-2 vaccine (Adults:only SPIKEVAX, Older adults: COMIRNATY or SPIKEVAX) and 6 months or more and 8 months or less after second dose.

Exclude criteria

Positive SARS-CoV-2 antigen test result at Screening.
A known history of SARS-CoV-2 infection as determined by medical interview before study intervention.
Participant has a contraindication to IM injections or blood draws.

Related Information

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