Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 3
- 主要终点
- Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
研究概览
简要总结
The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.
详细描述
The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.
The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 61 years of age or older 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.
排除标准
- •Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
- •Previous administration of a pandemic influenza vaccine.
- •Administration of any vaccine within 30 days before first vaccination.
- •Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
- •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 vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- •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 oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- •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 six months prior to the first vaccination.
- •Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
- •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- •An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- •Serious chronic disease as determined by medical history and physical examination.
- •Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
- •Any known or suspected allergy to any constituent of influenza vaccines.
- •History of chronic alcohol consumption and/or drug abuse.
- •Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
研究组 & 干预措施
Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
干预措施: Pandemrix (Influenza vaccine GSK2340272A) (Biological)
Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
干预措施: Fluarix™ (Biological)
Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
干预措施: Placebo (Biological)
Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
干预措施: Pandemrix (Influenza vaccine GSK2340272A) (Biological)
Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
干预措施: Fluarix™ (Biological)
Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
时间窗: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
时间窗: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
The GMFR is 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 Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
时间窗: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
次要结局
- Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains(Days 0, 21, 42, 182, 364)
- Number of Seroprotected Subjects(at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364)
- Number of Subjects With Titers Equal to or Above Titer 1:10(Days 0, 21, 42, 182, 364)
- Number of Subjects With Adverse Events of Specific Interest(From Day 0 to Day 364)
- Number of Subjects With Solicited Local and General Symptoms(Within 7 days (Day 0-Day 6) after each vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs)(From Day 0 to Day 83)
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 to Day 364)
- Number of Seroconverted Subjects(at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364)
- Geometric Mean Fold Rise (GMFR)(at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364)