A Phase 2/3 Study of S-268019 in Adults over 60 years of ages(COVID-19)

JRCT ID: jRCT2031220224

Registered date:26/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 25/07/2022
• Target sample size: 180
• Study type: Interventional
• Intervention(s): S-268019 (intramuscular injection) or COMIRNATY intramauscular injection

Outcome(s)

Primary Outcome

SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the fourth vaccination
The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, medically-attended AEs (MAAEs), or AEs of special interest (AESIs), vital signs

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participant aged 60 or over 60 years, at the time of signing the informed consent form (ICF).
Participants with at least 5 months and not greater than 8 months after completion of the third vaccination with an approved SARS-CoV-2 vaccine, COMIRNATY.
Male and female
Capable of giving signed ICF from participant, as stated in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclude criteria

Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.
Determined in the interview prior to the study intervention to have a history of SARS-CoV-2 infection.
Current history of poorly controlled 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.
Immunosuppressed (immunocompromised, having acquired immunodeficiency syndrome [AIDS], having received steroids and having received systemic immunosuppressants within 6 months prior to the first dose of study intervention, being treated for malignant tumors, being on 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