Prevention of COVID-19
Conditions
Interventions
S-268019 (intramuscular injection) or COMIRNATY intramauscular injection
Sponsors
Nagata Tsutae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed