EUCTR2012-000789-39-DE进行中（未招募）不适用
A Phase III, open, non-randomized, multi-centre, single dose study to assess immunogenicity and safety of Fluarix/Influsplit SSW 2012/2013 injected intramuscularly in adults (18 to 60 years) and in elderly (over 60 years). - FLUARIX-071
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •A male or female aged 18 years or above at the time of vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •A male or female aged 18 years or above at the time of vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
- •Administration of an influenza vaccine within the six months preceding the study vaccination.
- •Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
- •Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- •Acute disease and/or fever at the time of enrolment.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic underlying disease, not stabilized or clinically serious.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of Guillain-Barré syndrome.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Anaphylaxis following the administration of vaccine(s).
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
- •Administration of an influenza vaccine within the six months preceding the study vaccination.
- •Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
- •Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- •Acute disease and/or fever at the time of enrolment.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Chronic underlying disease, not stabilized or clinically serious.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of Guillain-Barré syndrome.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Anaphylaxis following the administration of vaccine(s).
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
研究者
相似试验
进行中（未招募）
不适用
A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ (Influsplit SSW®) 2007/2008 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). - Fluarix-064Immunization against influenza of healthy adultsMedDRA version: 9.1Level: LLTClassification code 10016794Term: Flu vaccinationEUCTR2007-001828-12-DEGlaxoSmithKline Biologicals
进行中（未招募）
不适用
A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ / Influsplit SSW® 2010/2011 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). - FLUARIX-068Immunization against influenza of healthy adultsMedDRA version: 12.1Level: LLTClassification code 10022000Term: InfluenzaEUCTR2010-019600-23-DEGlaxoSmithKline Biologicals
进行中（未招募）
不适用
A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ / Influsplit SSW® 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). - Fluarix-066 PRIEUCTR2008-001310-24-DEGlaxoSmithKline Biologicals120
进行中（未招募）
不适用
A Phase III, open, non-randomized, multi-centric, single dose study to assess mmunogenicity and safety of Fluarix / Influsplit SSW® 2009/2010 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). - Fluarix-067 PRIEUCTR2009-010811-34-DEGlaxoSmithKline Biologicals120
进行中（未招募）
不适用
Study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Biologicals combined hepatitis A / hepatitis B vaccine administered according to a 0, 6 month schedule versus Twinrix™ Junior administered according to a 0, 1, 6 month schedule in healthy children between 1 to 11 years old.Vaccination of healthy children from 1 to 11 years old against HepatitisEUCTR2015-001515-12-Outside-EU/EEAGlaxoSmithKline Biologicals511