NCT00680914已完成3 期
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 15
- 主要终点
- Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
研究概览
简要总结
The purposes of this study are:
To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life.
To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.
详细描述
Vaccination course at 2, 4, 6 months of age.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- •Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- •Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- •Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, 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 of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
- •A family history of congenital or hereditary immunodeficiency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- •Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
- •History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of any neurological disorders or seizures.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
结局指标
主要结局
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
时间窗: One month after administration of 3rd dose of the pneumococcal conjugate vaccine
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
次要结局
- Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Number of Subjects With Seroprotection Status Against PRP(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Number of Subjects Reporting Solicited Local Symptoms(Within 4 days after each vaccination)
- Number of Subjects With Solicited General Symptoms(Within 4 days after each vaccination)
- Number of Subjects Reporting Unsolicited Adverse Events(Within 31 days after each vaccination)
- Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Anti-PD Antibody Concentration(One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations(One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine)
- Number of Subjects With Serious Adverse Events (SAE)(Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5)
研究者
研究点 (15)
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