NCT00449670已完成3 期
Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,206
- 试验地点
- 7
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
研究概览
简要总结
The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.
详细描述
The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- •A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
排除标准
- •Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
- •Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups).
- •Previous vaccination with a pandemic candidate vaccine or a vaccine containing the same adjuvant as the study vaccine.
- •Previous proven contact with H5N1 wild type virus (i.e. contact with an individual with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry) which died as a result of H5N1 infection).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
- •History of hypersensitivity to vaccines.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of chronic alcohol consumption and/or drug abuse.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the candidate vaccine or during the study.
- •Lactating women.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
- •Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
时间窗: Within 21 days following 2-dose primary vaccination (at Day 42)
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.
次要结局
- Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D))
- Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease - Booster Phase(Following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D))
- Number of Seroprotected Subjects Against 2 Strains of Influenza Disease(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Booster Phase(During the 7-days (Days 0-6) post-booster vaccination period)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the booster phase (from Month 6 to Month 12))
- Number of Subjects With Serious Adverse Events (SAEs) for Subjects Not Boosted at Month 6(From Month 6 to Month 12)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6(At Day 0, at Day 21, at Day 42, at Month 6 and at Month 12)
- Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease in Adults Who Had Not Received the Booster Dose at Month 6(At Month 12)
- Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Received the Booster Dose at Month 6 - Booster Phase(At Month 12)
- Titers for Serum Neutralization (SN) Antibodies Against 2 Strains of Influenza Disease(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D))
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D) and at Month 12 (M12))
- Titers for Serum Neutralizing (SN) Antibodies Against 2 Strains of Influenza Disease(Before vaccination at Day 0 (D0) and within 21 days following 2-dose primary vaccination at Day 42 (D42))
- Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease(Within 21 days following 2-dose primary vaccination at Day 42)
- Number of Seroconverted Subjects for HI Antibodies Against 2 Strains of Influenza Disease for Adults Who Have Not Received Booster at Month 6(At Day 21, Day 42, Month 6 and Month 12 following primary vaccination)
- Number of Seroconverted Subjects for Neutralizing Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6(At Month 12)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease(Before booster vaccination at Month 6 (M6) and within 21 days following each booster dose: At Month 6 + 21 days (M6+21D) and, for H5N1 Un-adjuvanted Group only, at Month 6 + 42 days (M6+42D))
- Booster Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease(At Month 12)
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6(At Day 21, at Day 42, at Month 6 and at Month 12)
- Number of Subjects Seroprotected Against 2 Strains of Influenza Disease(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D) and at Month 6+42 days (M6+42D))
- Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12))
- Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6(At Month 6 and Month 12)
- Number of Subjects Seroprotected Against 2 Strains of Influenza Disease for Subjects Not Boosted at Month 6(At Day 0, Day 21, Day 42, Month 6 and Month 12)
- Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation(Before booster vaccination at Month 6 (M6) and following booster vaccination at Month 6+21 days (M6+21D), at Month 6+42 days (M6+42D) and at Month 12 (M12))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall)
- Frequency of Influenza-specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among the Analyzed Cytokines Upon in Vitro Stimulation for Subjects Not Boosted at Month 6(At Month 6 and at Month 12)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-days (Days 0-6) post-primary vaccination period following each dose and overall)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase(During the 7-days (Days 0-6) post-booster vaccination period)
- Number of Subjects With Serious Adverse Events (SAEs).(During the booster phase (from Month 6 to Month 12))
研究者
研究点 (7)
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