NCT00812981已完成3 期
Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
研究概览
简要总结
This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 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 should be enrolled in the study.
- •A male or female aged 18 to 60 years at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •Good general health as established by medical history and clinical examination before entering into the study.
- •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 other multiple-user device
- •Comprehension 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.
- •If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
排除标准
- •Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Diagnosed with cancer, or treatment for cancer, within 3 years.
- •An oral temperature ≥ 37.8 º C or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- •Receipt of systemic glucocorticoids (prednisone ≥ 5 mg/kg/day for more than 14 consecutive days) within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.
- •Any significant disorder of coagulation or treatment with Coumarin derivatives or Heparin.
- •Administration of any vaccines within 30 days before study enrolment.
- •Previous administration of any H5N1 vaccine.
- •Previous administration of vaccines with adjuvants similar to those used in the investigational vaccine.
- •Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrolment, or during the 180 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
- •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 known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- •Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to either vaccination.
- •Lactating women.
- •Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
- •Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
研究组 & 干预措施
1562902A NP GROUP
Experimental
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
干预措施: GSK1562902A (Biological)
1562902A CP GROUP
Experimental
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
干预措施: GSK1562902A (Biological)
结局指标
主要结局
Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
时间窗: At Day 42
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 A/Indonesia/05/2005.
次要结局
- Titers for Serum H5N1 HI Antibodies(At Day 0 and Day 180)
- Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value(At Days 0, 42 and 180)
- Number of Seroconverted Subjects Against Two Strains of Influenza Disease(At Day 42 and Day 180)
- Seroconversion Factor (SCF) for H5N1 HI Antibodies(At Day 42 and Day 180)
- Number of Seroprotected Subjects for H5N1 HI Antibodies(At Days 0, 42 and 180)
- Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease(At Days 0, 42 and 180)
- Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value(At Days 0, 42 and 180)
- Number of Seroconverted Subjects for Neutralizing Antibodies(At Day 42 and Day 180)
- 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 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 Subjects With Any Adverse Events of Specific Interest (AESIs)(From Day 0 up to 51 days after the first vaccination)
- Number of Subjects With Any AESIs(During the entire study period (from Day 0 up to Day 180))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the entire study period (from Day 0 up to Day 180))
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to Day 51)
- Number of Subjects With SAEs(During the entire study period (from Day 0 up to Day 180))
研究者
研究点 (2)
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