Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 845
- 试验地点
- 7
- 主要终点
- Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value
研究概览
简要总结
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule.
The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).
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
- 19 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who completed participation in primary phase of this study.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- •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 be post-menopausal; 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 4 weeks prior to enrolment in this study.
- •Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study
- •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 three months preceding the first visit or planned use during the study.
- •Pregnant or 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 visit, 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
Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value
时间窗: At Month 12 + 21 days
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.
Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
时间窗: At Month 12 + 21 days
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
时间窗: At Month 36 +21 days
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value
时间窗: At Month 36 + 21 days
Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Indonesia/05/2005.
Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
时间窗: At Month 36 + 21 days
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.
Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
时间窗: At Month 36 + 21 Days
Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer. The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
时间窗: At Month 36 + 21 days
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
时间窗: At Month 12 + 21 days
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Indonesia/05/2005.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
时间窗: At Month 12 + 21 days
GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
时间窗: At Month 12 + 21 days
Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Indonesia/05/2005.
次要结局
- Booster Vaccine Response for H5N1 HI Antibodies(At Months 36, 42 and 48)
- Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies(At Months 36, 42 and 48)
- Number of Seropositive Subjects for H5N1 HI Antibodies(At Months 42 and 48)
- Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12(At Months 18, 24 and 30)
- Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies(At Months 18, 24 and 30)
- Booster Vaccine Response for Neutralizing Antibodies(At Months 6/12/36 + 21 days, 12, 24, 36 and 48)
- Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)(At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36)
- Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies(At Months 36, 42 and 48)
- Titers for Serum Neutralizing Antibodies(At Months 6/12, 6/12 + 21 days, 24, 36 and 48)
- Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value(At Months 6/12/36 + 21 days, 12, 24, 36 and 48)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (From Month 12 up to Month 48))
- Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off(At Months 6/12/36 + 21 days, 12, 24, 36 and 48)
- Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)(At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 30-day (Days 0-29) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptom(During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36)
- Number of Subjects With Adverse Events of Specific Interest (AESIs)(During the entire study period (From Month 12 to Month 48))
- Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)(At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days)
- Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)(At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days)