jRCT2071230079招募中不适用
Multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy of COVID-19 vaccine (KD-414 (XBB.1.5) or KD-414 (JN.1)) when administered in healthy children aged 6 months to less than 13 years.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,374
- 主要终点
- The incidence of COVID-19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 6month old over 至 13age old not（—）
- 性别
- All
入选标准
- •(1) (Japanese) Healthy children aged 6 months to less than 13 years at the time of informed consent
- •(2) Those whose legally acceptable representatives provide written informed consent
排除标准
- •[XBB.1.5 part]
- •(1) Subjects who are infected with novel coronavirus (hereinafter referred to as SARS-CoV-2) or have a history of infection after February 2023 (based on the interview with the legally acceptable representatives)
- •(2) Subjects who have received a COVID-19 vaccine (including unapproved vaccines) within 6 months (180 days) (However, those who have received Omicron strain XBB.1.5 lineage vaccines including unapproved vaccines will be excluded regardless of the timing of vaccination.) (based on the interview with the legally acceptable representatives)
- •(3) Subjects with a known history of anaphylaxis due to the ingredient (thimerosal) of KD-414 (XBB.1.5)
- •(4) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before 28 days after the last dose of the study drug, or had menarche who do not agree to use contraceptive method (use of contraceptive devices and drugs, surgery, etc.)
- •(5) Subjects with fibrodysplasia ossificans progressive
- •(6) Subjects with a history of Guillain-Barre Syndrome or other demyelinating diseases
- •(7) Subjects with a history of capillary leak syndrome
- •(8) Subjects with clinically significant bleeding, or a history of significant bleeding or internal bleeding after intramuscular or intravenous injection
- •(9) Subjects with a history of thrombocytopenia or venous or arterial thrombosis associated with thrombocytopenia
- •(10) Subjects with known or suspected immunosuppression or immunodeficiency including asplenia syndrome
- •(11) Subjects who have participated in any other clinical study and received any other investigational product (excluding placebo) within 4 months (120 days) before the first dose of the study drug, who are planning to participate in any other clinical study during the study period, or who are scheduled to receive a COVID-19 vaccine
- •(12) Subjects who have received blood transfusion or administration of gamma globulin preparation within 3 months (90 days), or massive dose therapy of gamma globulin preparation (>=200 mg/kg) within 6 months (180 days) before the first dose of the study drug
- •(13) Subjects who have received any treatment* that may affect the immune function within 6months (180 days) before the first dose of the study drug *Radiotherapy, immunosuppressive drugs (external use is allowed), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone, corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/ day and for >=14days, but external use is allowed)
- •(14) Subjects with an underlying disease such as cardiovascular disease, renal disease, hepatic disease, hematological disease, developmental disorder, respiratory disease, and diabetes mellitus, whose symptoms are not stable, and who are judged by the investigator or subinvestigator to be difficult to participate in the study
- •(15) Subjects who are judged by the investigator or subinvestigator to be ineligible as subjects of this study for any other reason
- •[JN.1 part B]
- •(1) Subjects who are or whose family members in the same household are infected with SARS-CoV-2, or subjects who have a history of infection after December 2023 (based on the interview with the legally acceptable representatives)
- •(2) Subjects who have received a COVID-19 vaccine (including unapproved vaccines) within 6 months (180 days). (However, those who have received Omicron strain XBB.1.5 or JN.1 lineage vaccines including unapproved vaccines for both of them will be excluded regardless of the timing of vaccination.) (based on the interview with the legally acceptable representatives)
- •(3) to (15) are the same as those in the [XBB.1.5 part].
结局指标
主要结局
The incidence of COVID-19
时间窗: 15 to 105 days after the second dose
The incidence of COVID-19 during the period of 15 to 105 days after the second dose of the study drug
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
1 期
Study to investigate the efficacy and safety of dronabinol in the improvement of chemotherapy-induced and tumor-related symptoms in patients with advanced pancreatic cancer during first-line chemotherapyEUCTR2019-000616-28-ATAGMT gGmbH104
进行中（未招募）
不适用
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisrelapsing-remitting multiple scelorsisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2008-006786-92-ATActelion Pharmaceuticals Ltd400
进行中（未招募）
不适用
Multicenter, randomized, double-blind, placebo-controlled parallel group study to demonstrate the efficacy (quality of life) and safety of the standardized mistletoe extract PS76A2 during chemotherapy and follow-up in patients with breast cancerFemale patients with breast cancer shortly after surgery [pTNM classification: pT1-T4, pN0-N+ (0-9 positive lymph nodes), pM0] qualified for adjuvant chemotherapy according to FEC scheme as standard of careMedDRA version: 13.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-000841-36-PLRottapharm Madaus, Madaus GmbH320
进行中（未招募）
1 期
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosisrelapsing-remitting multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2008-006786-92-CZActelion Pharmaceuticals Ltd460
进行中（未招募）
不适用
Assessment of efficacy of CR8020 and CR6261, monoclonal antibodies, against influenza infectioInfluenzaEUCTR2013-003341-41-SECrucell Holland B.V.296