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

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

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Complete

Nov. 30, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

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.

"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."

Both

Prevention of COVID-19

S-268019 or COMIRNATY intramuscular injection for 5 to 11 years old (intramuscular injection)

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

+81-45-722-8655

No

none