EUCTR2009-013105-34-Outside-EU/EEA进行中（未招募）不适用
A PHASE I/II STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF A VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE IN HEALTHY INFANTS, CHILDREN AND ADOLESCENTS AGED 6 MONTHS TO 17 YEARS - Phase I/II Study of a H5N1 Vaccine in the Pediatric Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects will be eligible for participation in this study if:
- •They are 9 to 17ii years of age on the day of screening (for Stratum A
- •They are 3 to 8iii years of age on the day of screening (for Stratum B
- •They are 6 to 35iv months of age on the day of screening (for Stratum
- •They were born at full term of pregnancy (= 37 weeks) with a birth
- •weight = 2 kg (for Stratum C only);
- •They and/or their parents/legal guardians understand the nature and
- •procedures of the study and agree to its provisions;
- •Their parents/legal guardians provide written consent for participation
- •according to national law. In case the parents/legal guardians are
- •illiterate, the informed consent is also to be signed by an independent
- •They provide written assent according to their age and capacity of
- •understanding;
- •They are generally healthy, as determined by the investigator's clinical
- •judgment through collection of medical history and performance of a
- •physical examination;
- •They are physically and mentally capable of participating in the study
- •and follow its procedures;
- •They and/or their parents/legal guardians agree to keep a daily record
- •of symptoms for the duration of the study;
- •If female of childbearing potential – have a negative urine pregnancy
- •test result within 24 hours prior to the scheduled first vaccination and
- •agree to employ adequate birth control measures for the duration of the
- •ii From the 9th birthday to the last day before the 18th birthday
- •iii From the 3rd birthday to the last day before the 9th birthday
- •iv From 6 months of age to the last day before the 3rd birthday
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 670
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from participation in this study if:
- •They have a history of exposure to H5N1 virus or a history of
- •vaccination with an H5N1 influenza vaccine;
- •They are at high risk of contracting H5N1 influenza infection (e.g.
- •contact with poultry);
- •They currently have or have a history of a significant neurological,
- •cardiovascular, pulmonary (including asthma), hepatic, metabolic,
- •rheumatic, autoimmune, hematological or renal disorderv;
- •They have any inherited or acquired immunodeficiency;
- •They have a disease or are currently undergoing a form of treatment or
- •were undergoing a form of treatment within 30 days prior to study entry
- •that can be expected to influence immune response. Such treatment
- •includes, but is not limited to, systemic or high dose inhaled
- •corticosteroids, radiation treatment or other immunosuppressive or
- •cytotoxic drugs;
- •They have a history of severe allergic reactions or anaphylaxis;
- •They have a rash, dermatological condition or tattoos which may
- •interfere with injection site reaction rating;
- •They have received a blood transfusion or immunoglobulins or other
- •derivatives within 90 days prior to study entry;
- •They have received any live vaccine within 4 weeks or inactivated
- •vaccine within 2 weeks prior to vaccination in this study;
- •They have a functional or surgical asplenia;
- •They have a known or suspected problem with alcohol or drug abuse;
- •They were administered an investigational drug within 6 weeks prior
- •to study entry or are concurrently participating in a clinical study that
- •includes the administration of an investigational product;
- •They are in a dependent relationship with the study site personnel.
- •Dependent relationships include close relatives (i.e., children, siblings);
- •If female: are pregnant or lactating.
研究者
相似试验
进行中（未招募）
不适用
A clinical study to assess safety of and immune response to a whole virus H5N1 bird flu vaccine in children aged 6 months to 17 yearsProphylaxis of influenza infection caused by a pandemic influenza virus (H5N1)MedDRA version: 13.1Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2009-013105-34-FIBaxter Innovations GmbH670
未知
1 期
DNK-651-1JPRN-jRCT2080223171DENKA SEIKEN CO.,LTD.
进行中（未招募）
1 期
A PHASE II STUDY OF THE EFFICACY, SAFETY AND IMMUNOGENICITY OF ONCOVEX GM CSF IN PATIENTS WITH STAGE IIIc AND STAGE IV MALIGNANT MELANOMAStage IIIc and stage IV malignant melanomaEUCTR2006-003841-17-GBBioVex Inc60
未知
2 期
DNK-PEDFLU-2Prevention of influenza infectionJPRN-jRCT2080221243DENKA SEIKEN CO.,LTD.40
进行中（未招募）
1 期
Study to determine the safety and immunogenicity of COVID-eVax, a vaccine for COVID-19 in healthy adult volunteers.COVID-19 prevention.MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-003734-20-ITTakis S.r.l.160