EUCTR2014-000955-10-DE进行中（未招募）不适用
A Phase III, double-blind, randomized, multicenter study to assess safety and immunogenicity of GlaxoSmithKline Biologicals’ Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) manufactured with a new process, in adults aged 18 to 49 years and in children aged 6 months to 17 years. - FLU D-QIV-015
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,860
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
- •All subjects
- •Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- •Written informed consent obtained from the subject/their parent(s)/LAR(s) before any study procedure.
- •Written informed assent obtained from the subject if/as required by local regulations.
- •Subjects in stable health as determined by the investigator's clinical examination and assessment of subject's medical history.
- •Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.
- •Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •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 for 2 months after vaccination.
- •Pediatric cohort
- •United States:
- •A male or female subject between, and including, the ages of 3 and 17 years in the United States.
- •Rest of the World:
- •A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States.
- •All participating countries:
- •Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
- •Written informed assent obtained from the subject if/as required by local regulations.
- •Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
- •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 the vaccination series.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1740
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Adults aged 18-49 years cohort
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
- •Administration of an influenza vaccine during the 6 months preceding entry into the study.
- •Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- •Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- •Any history of Guillain-Barré Syndrome.
- •Acute disease and/or fever at the time of enrolment. Fever is defined as temperature = 38.0ºC/100.4ºF.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any contra-indication to intramuscular administration of influenza vaccines.
- •Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •Pediatric cohort
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
- •Administration of an influenza vaccine during the 6 months preceding entry into the study.
- •Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study
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