Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
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
- Single (Participant)
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
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- •Written informed consent obtained from the subject.
- •If the subject is female, she must be of non-childbearing potential, 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
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- •Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- •Confirmed influenza infection within a year preceding the study start.
- •Administration of an influenza vaccine during Northern Hemisphere season 2007-
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •History of hypersensitivity to a previous dose of influenza vaccine
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •History of administration of experimental/licensed vaccine.
研究组 & 干预措施
Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
干预措施: GSK Biologicals' quadrivalent influenza vaccine (Biological)
Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
干预措施: GSK Biologicals' quadrivalent influenza vaccine (Biological)
Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
干预措施: GSK Biologicals' trivalent influenza vaccine (Biological)
Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
干预措施: GSK Biologicals' trivalent influenza vaccine (Biological)
结局指标
主要结局
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
时间窗: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
次要结局
- Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.(At Days 0 and 21)
- Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.(During a 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.(At Day 21)
- HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains(Day 21)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During a 7 day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.(During a 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).(During a 21 day (Days 0-20) follow-up period after vaccination-)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Days 0-180))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During a 7-day follow-up period (Days 0-6) after vaccination)
- Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).(During the entire study period (Days 0-180))