Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 5
- 主要终点
- Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
研究概览
简要总结
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
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
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT
- •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.
- •A male or female subject aged 5 years at the time of study entry.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Child in care.
- •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.
- •Use of any investigational or non-registered product within 30 days prior to blood sampling.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
- •Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
结局指标
主要结局
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
时间窗: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).
时间窗: At Day 0
Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Number of Subjects With Serious Adverse Events (SAEs).
时间窗: During the entire study period (up to Day 46)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).
时间窗: At Day 0
A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
时间窗: At Day 0
A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
Concentrations of Antibodies Against Anti-D and Anti-T
时间窗: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).
时间窗: At Day 0
Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
Concentrations of Antibodies Against Anti-PRP.
时间窗: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Concentrations of Antibodies Against Anti-HBs.
时间窗: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL
时间窗: At Day 0
Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.
次要结局
未报告次要终点