A phase III, randomized, open, active-controlled study to evaluate the safety and immunogenicity of a prime-boost schedule of the H5N1 candidate vaccine adjuvanted with AS03B administered to children aged 3 to 17 years. - FLU D-PAN H5N1=AS03-032

GlaxoSmithKline Biologicals0 个研究点目标入组 520 人开始时间: 2012年4月12日最近更新: 2012年4月18日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals
入组人数: 520

研究概览入排标准研究者记录与标识符相似试验

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 must satisfy ALL the following criteria at study entry:
•Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .
•A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
•Written informed consent obtained from the subject’s parent or guardian. Assent obtained from the subject when applicable.
•Good general health as established by medical history and clinical examination before entering into the study.
•Comprehension by the subject’s parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
•Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
•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: 520
•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

•The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
•Child in care
•Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
•Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
•Active participation in other clinical trials.
•Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
•Acute disease and/or fever at the time of enrolment:
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
•Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
•An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
•Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
•Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
•History of seizures or progressive neurological disease.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•Diagnosed with cancer or any chronic severe disease.
•Previous administration of any H5N1 vaccine.

研究者

发起方

GlaxoSmithKline Biologicals

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