Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 831
- 试验地点
- 2
- 主要终点
- Anti-polio Type 1, 2 and 3 Antibody Titers
研究概览
简要总结
The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
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
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
- •Subjects who completed the full three-dose primary vaccination course in study NCT
- •Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
- •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
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the 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 the booster vaccination, or planned administration during the study period.
- •Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT
- •Serious chronic illness.
- •Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
- •Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
- •Encephalopathy
- •Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
- •Collapse or shock-like state within 48 hours of vaccination.
- •Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
- •Seizures with or without fever occurring within 3 days of vaccination.
- •The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- •Acute disease and/or fever at the time of enrolment.
研究组 & 干预措施
INFANRIX+HIB/POLIORIX 1 GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
干预措施: Infanrix+Hib™ (Biological)
INFANRIX+HIB/POLIORIX 1 GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
干预措施: Poliorix™ (Biological)
INFANRIX+HIB/POLIORIX 2 GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
干预措施: Infanrix+Hib™ (Biological)
INFANRIX+HIB/POLIORIX 2 GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
干预措施: Poliorix™ (Biological)
CONTROL GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
干预措施: Infanrix+Hib™ (Biological)
CONTROL GROUP
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
干预措施: Poliorix™ (Biological)
结局指标
主要结局
Anti-polio Type 1, 2 and 3 Antibody Titers
时间窗: One month after the booster vaccination (At Month 1)
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
时间窗: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
时间窗: Before the booster vaccination (At Day 0)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Anti-D and Anti-T Antibody Concentrations
时间窗: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
时间窗: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
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) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Number of Seroprotected Subjects Against PRP
时间窗: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
时间窗: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
时间窗: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
时间窗: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
时间窗: One month after the booster vaccination (At Month 1)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
时间窗: One month after the booster vaccination (At Month 1)
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
时间窗: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
次要结局
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 up to Month 1))
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period)