NCT00814710已完成3 期
Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- Concentration of Antibody Against Protein D (PD)
研究概览
简要总结
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.
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 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between, and including 6-10 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.
- •Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- •Free of any known or suspected health problems (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) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •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 (with the exception of hepatitis B immunoglobulins at birth).
- •Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
- •History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and 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.
- •Babies for which birth weight is < 2 kilogram.
结局指标
主要结局
Concentration of Antibody Against Protein D (PD)
时间窗: One month after primary immunization (month 3)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
时间窗: One month after primary immunization (month 3)
Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
次要结局
- Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes(One month after primary immunization (month 3))
- Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)(One month after primary immunization (month 3))
- Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).(One month after primary immunization (month 3))
- Number of Subjects Seropositive for Protein D (PD)(One month after primary immunization (month 3))
- Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)(One month after primary immunization (month 3))
- Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)(One month after primary immunization (month 3))
- Number of Subjects Seropostive for B. Pertussis(One month after primary immunization (month 3))
- Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)(One month after primary immunization (month 3))
- Number of Subjects Seropositive for Pneumococcal Serotypes(One month after primary immunization (month 3))
- Number of Subjects With Serious Adverse Events (SAEs)(Following first vaccination (Month 0) throughout the entire study period (month 3))
- Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes(One month after primary immunization (month 3))
- Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value(One month after primary immunization)
- Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)(One month after primary immunization (month 3))
- Number of Subjects With Solicited Local and General Symptoms(Within 4 days (day 0-3) after vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within 31 days (day 0-30) after vaccination)
研究者
研究点 (5)
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