Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 745
- 试验地点
- 4
- 主要终点
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
研究概览
简要总结
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
详细描述
- Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.
- Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.
- Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.
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
- None
入排标准
- 年龄范围
- 10 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tritanrix-HepB/Hiberix Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB/Hiberix™ Kft. (Biological)
Tritanrix-HepB/Hiberix Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB/Hiberix™ Kft. (Biological)
PRP Tritanrix-HepB Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB Kft (Biological)
Tritanrix-HepB/Hiberix Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB/Hiberix™ (Biological)
HB Tritanrix-HepB/Hiberix Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB/Hiberix™ Kft. (Biological)
Tritanrix-HepB Kft.+Hiberix Group
Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
干预措施: Hiberix™ (Biological)
Tritanrix-HepB Kft.+Hiberix Group
Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB Kft (Biological)
PRP Tritanrix-HepB Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB/Hiberix™ Kft. (Biological)
PRP Tritanrix-HepB Kft. Mix Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Polyribosil-Ribitol-Phosphate (PRP) vaccine (Biological)
PRP Tritanrix-HepB Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB/Hiberix™ (Biological)
PRP Tritanrix-HepB Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Polyribosil-Ribitol-Phosphate (PRP) vaccine (Biological)
PRP Tritanrix-HepB Kft. Ref Group
Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
干预措施: Tritanrix™-HepB Kft (Biological)
结局指标
主要结局
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
时间窗: At Month 1, post-booster vaccination
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
时间窗: At Month 1, post-booster vaccination
A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
时间窗: At Month 1, post-booster vaccination
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
时间窗: At Month 1, post-PRP challenge
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.
Seroprotection Rates for Anti-D Antibodies
时间窗: At Month 1, post-booster vaccination
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)
时间窗: At Month 1, post-booster vaccination
A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).
Number of Subjects With Booster Response to BPT Antigen
时间窗: At Month 1, post-booster vaccination
The booster response was defined as: * an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration \< 15 EL.U/mL) prior to administration of the booster dose; or * at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.
Anti-PRP Antibody Concentrations
时间窗: At Month 1, post-PRP challenge
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Anti-PRP Antibody Concentrations.
时间窗: At Month 1, post-booster vaccination
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Anti-D and Anti-T Antibody Concentrations
时间窗: At Month 1, post-booster vaccination
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Anti-HBs Antibody Concentrations
时间窗: At Month 1, post-booster vaccination
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Anti-BPT Antibody Concentrations
时间窗: At Month 1, post-booster vaccination
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
次要结局
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL(At Month 0, prior to the PRP challenge)
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.(At Month 0, prior to the PRP challenge)
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value(At Month 0, prior to the PRP challenge)
- Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value(At Month 0, prior to the PRP challenge)
- Anti- PRP Antibody Concentrations(At Month 0, prior to the PRP challenge)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-Day (Days 0-3) post-PRP challenge)
- Seroprotection Rates for Anti-D Antibodies(At Month 0, prior to the PRP challenge)
- Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value(At Month 0, prior to the PRP challenge)
- Anti-HBs Antibody Concentrations.(At Month 0, prior to the PRP challenge)
- Anti-BPT Antibody Concentrations.(At Month 0, prior to the PRP challenge)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-Day (Days 0-3) post-PRP challenge)
- Anti- PRP Antibody Concentrations.(At Month 0, prior to the PRP challenge)
- Anti-D and Anti-T Antibody Concentrations.(At Month 0, prior to the PRP challenge)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 4-Day (Days 0-3) post-booster vaccination period)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 4-Day (Days 0-3) post-booster vaccination period)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-Day (Day 0-30) follow-up period)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 to Month 9.5))