Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43,695
- 试验地点
- 275
- 主要终点
- Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.
详细描述
This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.
After the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in Romania, which enrolled 102 subjects in the trial. Because evaluation of data from this site did not reveal irregularities when compared with overall study data and because GSK has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older 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.
- •A man or woman aged 65 years or older at the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Subjects with residence status allowing free mixing with general community.
排除标准
- •Bedridden subjects
- •Previous vaccination against influenza since February
- •Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Any contra-indication to intramuscular administration of the influenza vaccines.
- •History of hypersensitivity to a previous dose of influenza vaccine.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
- •Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).
研究组 & 干预措施
FluNG Group
subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
干预措施: GSK Bio's influenza vaccine GSK2186877A (Biological)
Fluarix Group
subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
干预措施: Fluarix TM (Biological)
结局指标
主要结局
Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.
时间窗: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
时间窗: After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))
Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.
次要结局
- Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.(During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010))
- Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.(During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010))
- Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.(During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009))
- Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine(During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009))
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).(During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010))
- Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).(During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010))
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.(During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009))
- Number of Days With Any Grade of Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009))
- Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.(During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009))
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010))
- Number of Days With Any Grade of Solicited Local Symptoms.(During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010))
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009))
- Number of Days With Any Grade of Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009))
- Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.(During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010))
- Number of Days With Any Grade of Solicited General Symptoms.(During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010))
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).(Within 21 days (Days 0-20) after the second dose (Year 2009/2010))
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit(Within 180 days (Days 0-179) after the first dose (Year 2008/2009))
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.(Within 180 days (Days 0-179) after the second dose (Year 2009/2010))
- Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.(At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study)
- Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains(At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study)
- Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains(At Day 21 of the first year (2008/2009) of the study.)