A Phase 2/3, Randomized, Active-controlled, Observer-blinded, Non-inferiority Study to Evaluate the Safety and Immunogenicity of Booster Immunization with DS-5670a/b (Bivalent: Original Strain/Omicron Strain BA.4-5) in Subjects Aged 5 to 11 Years Who Have Completed Initial Immunization with Comirnaty Intramuscular Injection (Univalent: Original Strain)

Phase 2

• Conditions: Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)

• Registration Number: JPRN-jRCT2031220665
• Lead Sponsor: Inoguchi Akihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-28
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion 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)Having completed initial immunization with Comirnaty IM in the past, with at least 3 months elapsed since the 2nd dose.
4) Able to comply with the rules of the study, undergo physical examinations and tests that are specified in the protocol, and report symptoms or other issues.

Exclusion 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 for SARS-CoV-2 infection (based on reverse transcription polymerase chain reaction [RT-PCR], other nucleic acid detection methods, or SARS-CoV-2 antigen test) within 3 months before informed consent, or having been diagnosed with coronavirus disease 2019 (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 antibody test at the time of eligibility evaluation, with symptoms suspected of SARS-CoV-2 infection (eg, respiratory symptoms, headache, malaise, anosmia, dysgeusia, pharyngeal pain) within 3 months before informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified