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

JRCT ID: jRCT2031210470

Registered date:06/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 03/12/2021
• Target sample size: 204
• Study type: Interventional
• Intervention(s): S-268019 or COMIRNATY (intramuscular injection)

Outcome(s)

• Primary Outcome: SARS-CoV-2 neutralizing antibody titer on Day 29

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 COMIRNATY and at least 6 months post 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