NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031220493

Registered date:08/12/2022

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPrevention of COVID-19
Date of first enrollment30/11/2022
Target sample size150
Countries of recruitment
Study typeInterventional
Intervention(s)S-268019 or COMIRNATY intramuscular injection for 5 to 11 years old (intramuscular injection)

Outcome(s)

Primary OutcomePrimary 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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 5age old
Age maximum< 12age old
GenderBoth
Include criteriaParticipant 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

Contact

Public contact
Name Corporate Communications Department
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.
Scientific contact
Name Juan Carlos Gomez
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.