A Phase 1/2/3 Study of S-268019 in Participants Aged 5 to 11 Years (Part 2)(COVID-19)

JRCT ID: jRCT2031220493

Registered date:08/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 30/11/2022
• Target sample size: 150
• Study type: Interventional
• Intervention(s): S-268019 or COMIRNATY intramuscular injection for 5 to 11 years old (intramuscular injection)

Outcome(s)

Primary Outcome

Primary vaccination part
GMT and seroconversion rate of SARS-CoV-2 neutralizing antibody titer on Day 57
Booster vaccination part
GMT and seroresponse rate of SARS-CoV-2 neutralizing antibody titer on Day 239

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 12age old
• Gender: Both

Include criteria

Participant aged 5 to 11 years, at the time of signing the informed consent form (ICF).
Male and female.
Capable of giving signed ICF from parent(s) or legal guardian of participant and obtained assent from participant, as stated in the protocol which includes compliance with the requirements and restrictions listed in the ICF/informed assent form (IA) 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.
Receiving anticoagulation therapy, or having thrombocytopenia or coagulopathy.
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.
Participant weighing under 10 kg."

Related Information

• Primary Sponsor: Gomez Juan Carlos
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare