jRCT2011220011Active, not recruitingNot Applicable
A Phase 1/2/3, Randomized, Observer-Blind Study of S-268019 in Participants Aged 5 to 11 Years (Part 1)(COVID-19)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Shionogi & Co., Ltd.
- Enrollment
- 48
- Primary Endpoint
- incidence of adverse events (AEs)
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
- 5age 0month 0week old over to 12age old not (—)
- Sex
- All
Inclusion 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.
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.
- •Participant weighing under 10 kg
Outcomes
Primary Outcomes
incidence of adverse events (AEs)
The incidence of adverse events (AEs)
incidence of adverse reactions
The incidence of adverse reactions
incidence of serious AEs (SAEs)
The incidence of serious AEs (SAEs)
incidence of solicited AEs
The incidence of solicited AEs
incidence of medically-attended AEs (MAAEs)
The incidence of medically-attended AEs (MAAEs)
incidence of AEs of special interest (AESIs)
The incidence of AEs of special interest (AESIs)
vital signs
Vital signs
ECG
ECG
Secondary Outcomes
No secondary outcomes reported
Investigators
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