Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 14
- 主要终点
- Number of Subjects Reporting Grade 3 Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between, and including, 12-18 months of age at the time of booster vaccination.
- •Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- •Subjects who received three doses of pneumococcal conjugate vaccine in study NCT
- •Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- •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) within 30 days preceding the vaccination, or planned use during the study period.
- •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 (pharmaceutical product or device).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- •Administration of any pneumococcal and/or Hib vaccine since the end of study NCT
- •Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
- •Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- •Acute disease at the time of enrolment.
研究组 & 干预措施
Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
干预措施: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A) (Biological)
Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
干预措施: GSK Biologicals' Hiberix™ (Biological)
Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
干预措施: Wyeth-Lederle's Prevenar™ (Biological)
Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
干预措施: GSK Biologicals' Hiberix™ (Biological)
结局指标
主要结局
Number of Subjects Reporting Grade 3 Adverse Events
时间窗: Within 31 days (Day 0 - Day 30) after booster vaccination.
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
次要结局
- Number of Subjects Reporting Serious Adverse Events(After booster vaccination up to study end (Month 0 to Month 1))
- Concentration of Antibodies Against Vaccine Pneumococcal Serotypes(One month after booster vaccination (Month 1))
- Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)(One month after booster vaccination (Month 1))
- Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes(One month after booster vaccination (Month 1))
- Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A(One month after booster vaccination (Month 1))
- Number of Subjects Reporting Solicited Symptoms(Within 4 days (Days 0 to 3) after booster vaccination)
- Number of Subjects Reporting Unsolicited Adverse Events(Within 31 days (Days 0 to 30) after booster vaccination)
- Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A(One month after booster vaccination (Month 1))
- Concentration of Antibodies Against Protein D (PD)(One month after booster vaccination (Month 1))