NCT00835237已完成3 期
Evaluation of GSK Biologicals' Boostrix® Vaccine When Compared With Decavac™ in Adults Aged 65 Years or Older.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,332
- 试验地点
- 25
- 主要终点
- Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
研究概览
简要总结
This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.
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 can and will comply with the requirements of the protocol should be enrolled in the study.
- •Males or females 65 years of age and older at the time of study entry.
- •Free of an acute aggravation of the health status as established by medical history and medical history and clinical examination before entering into the study.
- •Written informed consent from all subjects.
排除标准
- •Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
- •Administration of a Tdap vaccine at any time prior to study entry.
- •History of diphtheria and/or tetanus and/or pertussis disease.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
- •Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination.
- •Planned administration of any vaccine not foreseen by the study protocol up to 30 days following vaccination, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of the investigator when the subject comes back at Visit
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •History of serious allergic reaction following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
- •History of encephalopathy within seven days of administration of a previous booster dose of pertussis vaccine that is not attributable to another identifiable cause.
- •Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
- •Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- •Acute disease at the time of vaccination.
- •Administration of immunoglobulins and/or any blood products within the three months preceding vaccination, or planned administration during the study period.
- •Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
结局指标
主要结局
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
时间窗: One month after vaccination.
Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
时间窗: Before (PRE) and one month after vaccination (POST)
Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)
次要结局
- Number of Subjects Reporting Solicited Local Symptoms(Within the 4-day (Day 0-3) post-vaccination period)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(Within the 31-day (Day 0-30) post-vaccination period)
- Anti-T and Anti-D Antibody Concentrations(Before (PRE) and one month after vaccination (POST))
- Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off(One month after vaccination)
- Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off(One month after vaccination)
- Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.(One month after vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAE)(From the vaccination up to Day 182)
- Number of Subjects Reporting Solicited General Symptoms(Within the 4-day (Day 0-3) post-vaccination period)
研究者
研究点 (25)
Loading locations...
相似试验
已完成
4 期
Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old AdolescentsAcellular PertussisDiphtheriaTetanusNCT01362322GlaxoSmithKline671
已完成
4 期
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant WomenDiphtheria-Tetanus-acellular Pertussis VaccinesNCT02377349GlaxoSmithKline688
已完成
4 期
Evaluation of Boostrix™10 Years After Previous Booster VaccinationAcellular PertussisDiphtheriaTetanusNCT01147900GlaxoSmithKline180
已完成
2 期
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative AdolescentsTuberculosisNCT00950612GlaxoSmithKline60
已完成
4 期
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)Acellular PertussisTetanusDiphtheriaNCT01294605GlaxoSmithKline460