Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Anti-polio Types 1, 2 and 3 Antibody Titers
研究概览
简要总结
The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.
详细描述
The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
- •Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) 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 other than the study vaccine(s) 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 (up to Visit 2).
- •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.
- •History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
- •Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •History of neurologic disorders or seizures.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •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.
- •Child in care.
- •Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- •encephalopathy of unknown aetiology occurring within seven 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 within 48 hours of vaccination,
- •convulsions with or without fever, occurring within 3 days of vaccination.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
- •Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
- •Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
研究组 & 干预措施
GSK2036874A GROUP 2
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
干预措施: GSK2036874A vaccine (Biological)
GSK2036874A GROUP 1
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
干预措施: GSK2036874A vaccine (Biological)
GSK2036874A GROUP 3
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
干预措施: GSK2036874A vaccine (Biological)
ZILBRIX/HIB/POLIORIX GROUP
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
干预措施: Zilbrix™/Hib vaccine (Biological)
ZILBRIX/HIB/POLIORIX GROUP
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
干预措施: Poliorix™ (Biological)
结局指标
主要结局
Anti-polio Types 1, 2 and 3 Antibody Titers
时间窗: One month after booster vaccination (At Month 1)
Antibody titers were presented as geometric mean titers (GMTs).
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
时间窗: One month after booster vaccination (At Month 1)
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
次要结局
- Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3(One month after booster vaccination (At Month 1))
- Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3(Prior to booster vaccination (At Month 0))
- Anti-BPT Antibody Concentrations(Prior to (At Month 0) and one month after booster vaccination (At Month 1))
- Number of Subjects With a Booster Response for Anti-BPT(One month after booster vaccination (At Month 1))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-Day 30) post-vaccination period)
- Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)(Prior to (At Month 0) and one month after the booster vaccination (At Month 1))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 to Month 1))
- Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)(Prior to (At Month 0) and one month after booster vaccination (At Month 1))
- Anti-D and Anti-T Antibody Concentrations(Prior to (At Month 0) and one month after booster vaccination (At Month 1))
- Anti-HBs Antibody Concentrations(Prior to (At Month 0) and one month after the booster vaccination (At Month 1))
- Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)(Prior to (At Month 0) and one month after booster vaccination (At Month 1))
- Number of Subjects With Any Solicited Local Symptoms(During the 8-day (Days 0-7) post-vaccination period)
- Number of Subjects With Any Solicited General Symptoms(During the 8-day (Days 0-7) post-vaccination period)
- Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)(Prior to (At Month 0) and one month after the booster vaccination (At Month 1))
- Anti-PRP Antibody Concentrations(Prior to (At Month 0) and one month after booster vaccination (At Month 1))