Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 7
- 主要终点
- Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
研究概览
简要总结
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
详细描述
This protocol posting has been updated in order to comply with the 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
- 16 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- •Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study
- •A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
- •Written informed consent obtained from the parent or guardian of the subject
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) 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 vaccine dose.
- •Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- •Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
结局指标
主要结局
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Subjects With a Vaccine Response to PT, FHA and PR
时间窗: One month after the booster vaccination (At Month 1)
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).
Anti-D and Anti-T Antibody Concentrations
时间窗: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
时间窗: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
时间窗: One month after the booster vaccination (At Month 1)
Antibody titers were presented as geometric mean titers (GMTs).
Anti-PRP Antibody Concentrations
时间窗: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Anti-HBs Antibody Concentrations
时间窗: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
次要结局
- Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seroprotected Subjects Against PT, FHA and PRN(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-HBs Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-poliovirus Type 1, 2 and 3 Antibody Titers(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-D and Anti-T Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after the booster vaccination)
- Anti-PRP Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Subjects With a Vaccine Response to PT, FHA and PR(One month after the booster dose (At Month 1))
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after the booster vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period after the booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(From Month 0 to Month 1, during the entire study period)
- Number of Subjects Reporting Concomitant Medications(During the 4-day (Days 0-3) follow-up period after the booster vaccination)