NCT00979407已完成3 期
Immunological Equivalence Between GSK2340272A and GSK2340274A Influenza Vaccines in Adults Aged 18 to 60 Years
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 8
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
研究概览
简要总结
The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.
详细描述
This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to removal of one of the secondary outcome measures.
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
- Double (Participant, Investigator)
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
- •Male or female aged 18 to 60 years inclusive, at the time of the first vaccination.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •Satisfactory baseline medical assessment by history and physical examination.
- •Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device
- •Females of non-childbearing potential may be enrolled in the study.
- •Female of childbearing potential may be enrolled in the study, if she:
- •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.
排除标准
- •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.
- •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Presence of an axillary temperature >= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
- •Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- •Diagnosed with cancer, or treatment for cancer, within 3 years.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- •Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- •Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
- •Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
- •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- •An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- •Administration of any vaccines within 30 days before vaccination.
- •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- •Pregnant or lactating female
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
研究组 & 干预措施
GSK2340272A GROUP
Experimental
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
干预措施: Influenza vaccine GSK2340272A (Biological)
GSK2340274A GROUP
Experimental
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340274A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
干预措施: Influenza vaccine GSK2340274A (Biological)
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
时间窗: At Day 21
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.
次要结局
- Number of Seroconverted (SCR) Subjects for HI Antibodies(At Days 21 and 42)
- Number of SCR Subjects for HI Antibodies(At Days 182 and 364)
- Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Days 182 and 364)
- Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Days 182 and 364)
- Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Days 182 and 364)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Days With Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Days With Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Potential Immune-mediated Diseases (pIMDs)(From Day 0 up to Day 42)
- Number of Subjects With pIMDs(During the entire study period (from Day 0 up to Day 364))
- Number of Subjects With Any Adverse Event of Special Interest (AESIs)(During the entire study period (from Day 0 up to Day 364))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Day 364))
研究者
研究点 (8)
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