Immunological Non-inferiority Between Two Process-manufactured Influenza Vaccines in Adults Aged 18 to 60 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
研究概览
简要总结
The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •All subjects must satisfy ALL the following criteria at study entry:
- •A male or female aged 18 to 60 years of age 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.
- •Female subjects of non-childbearing potential may be enrolled in the study. 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.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) 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.
- •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.
- •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 coumarin derivatives, other vitamin K antagonists or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- •Any contraindication to intramuscular administration of the influenza vaccines.
- •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 New 1D Group
Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
干预措施: GSK investigational vaccine GSK2340272A (Biological)
GSK2340272A New 2D Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) 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: GSK investigational vaccine GSK2340272A (Biological)
GSK2340272A INI 1D Group
Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
干预措施: GSK investigational vaccine GSK2340272A (Biological)
GSK2340272A INI 2D Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) 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: GSK investigational vaccine GSK2340272A (Biological)
结局指标
主要结局
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
时间窗: At Day 21
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains 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 ≥ 1:10.
次要结局
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease(At Days 182 and 364)
- Number of Days With Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and overall)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Days 0 and 42)
- 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 Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Days 182 and 364)
- 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)
- Number of Days With Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and overall)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Day 364))
- Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain(At Days 182 and 364)
- Number of Subjects With Potential Immune-mediated Diseases (pIMDs)(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 and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84))
- 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, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)