A phase III, randomized, active-comparator, observer-blind, non-inferiority study to demonstrate the immunogenicity and safety of DS-5670d (monovalent: omicron XBB.1.5) in children 5 through 11 years of age

JRCT ID: jRCT2031230423

Registered date:24/10/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Prevention of infection due to SARS-CoV-2
• Date of first enrollment: 05/01/2024
• Target sample size: 360
• Study type: Interventional
• Intervention(s): A dose of either DS-5670d (0.2 mL) or Comirnaty IM (0.2 mL) will be intramuscularly administered to the deltoid muscle of the upper arm.

Outcome(s)

Primary Outcome

-The GMT of blood neutralising activity against SARS-CoV-2 (Omicron XBB.1.5) at 4 weeks after the administration in children 5 through 11 years of age with at least one of SARS-CoV-2 infection history and SARS-CoV-2 vaccination history.
- The seroresponse rate of blood neutralising activity against SARS-CoV-2 (Omicron XBB.1.5) at 4 weeks after the administration in children 5 through 11 years of age with at least one of SARS-CoV-2 infection history and SARS-CoV-2 vaccination history.

Secondary Outcome

-The GMT of blood neutralising activity against SARS-CoV-2 (Omicron XBB.1.5) at 4 weeks after the administration in children 5 through 11 years of age regardless of SARS-CoV-2 infection history and SARS-CoV-2 vaccination history.
-The seroresponse rate of blood neutralising activity against SARS-CoV-2 (Omicron XBB.1.5) at 4 weeks after the administration in children 5 through 11 years of age regardless of SARS-CoV-2 infection history and SARS-CoV-2 vaccination history.

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: <= 11age old
• Gender: Both

Include criteria

1) Subjects aged 5 to 11 years at the time of informed consent.
2) Having provided written consent to study participation via the legal representative.
3) Able to comply with the rules of the study, record symptoms via electronic diary by his/her legal representative, undergo physical examinations and tests that are specified in the protocol, and report symptoms or other issues (report from his/her legal representative to be available).

Exclude criteria

1) Having any serious cardiovascular, renal, hepatic, blood, neuropsychiatric, developmental disorder, thrombocytopenia, or coagulopathy.
2) Having a medical history of vaccination-related convulsions or epilepsy.
3) Having a concurrent or medical history of myocarditis or pericarditis.
4) Having tested positive within 3 months before informed consent for SARS-CoV-2 infection (based on RT-PCR, other nucleic acid detection methods, or SARS-CoV-2 antigen test), or having been diagnosed with COVID-19 based on a physician's examination.
5) Having been diagnosed with immunodeficiency in the past or having a close relative with congenital immunodeficiency.
6) Having symptoms suspected of SARS-CoV-2 infection (eg, respiratory symptoms, headache, malaise, anosmia, dysgeusia, pharyngeal pain) at the time of informed consent.
7) Having tested positive for SARS-CoV-2 antigen test at the time of eligibility evaluation.
8) Having tested positive for SARS-CoV-2 antibody test at the time of eligibility evaluation, with symptoms suspected ofSARS-CoV-2 infection (eg, respiratory symptoms, headache, malaise, anosmia, dysgeusia, pharyngeal pain) within 3 months before informed consent.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare