A Booster Study of S-268019 in Participants Aged 5 to 11 Years (COVID-19)

A Phase 3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity of the booster dose of S-268019 to the COMIRNATY intramuscular injection in participants aged 5 to 11 years (COVID-19)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220530

Enrollment

100

Registered

2022-12-23

Start date

2023-01-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of COVID-19

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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. 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.

Design outcomes

Primary

Measure	Time frame
GMT and seroresponse rate of SARS-CoV-2 neutralizing antibody titer on Day 29	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026