JPRN-jRCT2031220665进行中（未招募）2 期
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)
Inoguchi Akihiro0 个研究点目标入组 210 人开始时间: 2023年2月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 <= 11age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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