NCT00610168已完成4 期
Evaluation of GSK Biologicals' dTpa Booster Vaccine in Young Adults 10 Years After Previous dTpa Boosting.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
详细描述
This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 24 Years（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 should be enrolled in the study.
- •Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/
- •A male or female subject, recruited 10 years after booster vaccination in study 263855/
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
- •Written informed consent obtained from the subject.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination or planned administration during the active study period.
- •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.
- •Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/
- •History of documented diphtheria, tetanus, or pertussis diseases.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :
- •hypersensitivity reaction to any component of the vaccine,
- •encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
- •fever >= 40°C within 48 hours of vaccination not due to another identifiable cause,
- •collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
- •convulsions with or without fever, occurring within 3 days of vaccination.
- •Acute disease at the time of enrolment.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
结局指标
主要结局
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
时间窗: At Month 1
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
次要结局
- Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations(At Month 0 (PRE) and Month 1 (POST))
- Number of Subjects With Serious Adverse Events (SAEs)(For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group))
- Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)(At Month 0 (PRE) and Month 1 (POST))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Day 0-3) follow-up period after booster vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period after booster vaccination)
- Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)(At Month 1)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period after booster vaccination)
- Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations(At Month 0 (PRE) and Month 1 (POST))
研究者
研究点 (2)
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