jRCT2031220224CompletedNot Applicable
A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity of the fourth dose of S-268019 to the COMIRNATY intramuscular injection in Adults over 60 years of ages (COVID-19)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shionogi & Co., Ltd.
- Enrollment
- 180
- Primary Endpoint
- SARS-CoV-2 neutralizing antibody (NAb) titer
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 60age 0month 0week old over to No limit (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
SARS-CoV-2 neutralizing antibody (NAb) titer
Time Frame: 28 days following the fourth vaccination
SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the fourth vaccination
Incidence of adverse events
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
Vital signs
Secondary Outcomes
No secondary outcomes reported
Investigators
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