Single-blind, Clinical Study of the Immunogenicity and Reactogenicity of SB Biologicals' dTpa, pa Vaccines and a Td Vaccine, Given as a Booster Dose to Healthy Adults, From the Age of 18 Years Onwards
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 550
- 主要终点
- Occurrence of solicited local and general symptoms
研究概览
简要总结
The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age at the time of the vaccination
- •Written informed consent has been obtained
排除标准
- •Evidence of confirmed pertussis disease within the previous 5 years
- •History of diphtheria or tetanus vaccination within the past 5 years Females must not be pregnant or lactating They must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination.
- •History of diphtheria or tetanus disease
- •History of allergic disease likely to be stimulated by the vaccination
- •Major congenital defects or serious chronic illness
- •History of progressive neurological disease
- •Immunosuppressive therapy
- •Any suspected or confirmed immune disorder
- •Immunoglobulin therapy or administration of any blood products within the previous three months or during the study period
- •Acute febrile illness (>37.5°C, axillary or oral temperature) at the time of planned vaccination
- •Administration of an investigational or non registered drug or vaccine within 30 days prior to the start of the present trial
- •Simultaneous administration of a vaccine not foreseen by the study protocol, within 30 days prior to the start of the present trial
- •Any severe or serious adverse experience having occurred after previous administration of DTP vaccine i.e:
- •an immediate anaphylactic or unacceptable reaction to the investigator's opinion, to a previous dose of diphtheria tetanus pertussis whole-cell vaccine, i.e. :
- •encephalopathy
- •fever > 40.5°C (105°F), rectal temperature, occurring after vaccination with diphtheria tetanus pertussis whole-cell vaccine and not due to another identifiable cause.
- •collapse or shock-like state
- •persistent, inconsolable crying lasting > 3 hours
- •seizures with or without fever
- •systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine
- •Exclusion from long term follow-up of antibody persistence : Evidence of confirmed pertussis, diphtheria or tetanus disease or vaccination against these diseases since previous study visit
研究组 & 干预措施
Group A
Subjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
干预措施: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine (Biological)
Group B
Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
干预措施: GSK Biologicals' acellular pertussis vaccine (Biological)
Group B
Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
干预措施: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine (Biological)
Group C
Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
干预措施: GSK Biologicals' acellular pertussis vaccine (Biological)
Group C
Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
干预措施: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine (Biological)
结局指标
主要结局
Occurrence of solicited local and general symptoms
时间窗: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection
次要结局
- Immunogenicity with respect to components of the study vaccines(2, 3, 4 and 5 years after the vaccination)
- Occurrence of solicited local symptoms and fever(Within the 15-day (Day 0 - Day 14) follow-up period after the second injection)
- Occurrence of general solicited symptoms to vaccination, other than fever(Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration)
- Occurrence of unsolicited symptoms(Within 31 days (Day 0 - Day 30) after each vaccine administration)
- Occurrence of serious adverse experiences to vaccination(Within 31 days (Day 0 - Day 30) after each vaccine administration)
- Immunogenicity with respect to components of the study vaccines(One year after the vaccination in a subset of subjects from all the groups)
- Immunogenicity with respect to components of the study vaccines(One month after the first injection)
- Immunogenicity with respect to components of the study vaccines(One month after the second injection)
- Immunogenicity with respect to components of the study vaccines(Immediately prior to the booster vaccination)