NCT01027845已完成3 期
Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline Biologicals' Pneumococcal Vaccine GSK1024850A Following Primary and Booster Vaccination of Healthy Japanese Children
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
- 17
- 主要终点
- Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
研究概览
简要总结
This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 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
- None
入排标准
- 年龄范围
- 90 Days 至 118 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
- •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.
- •Born after a gestation period of 36 to 42 weeks inclusive.
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 study vaccine(s), or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
- •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).
- •Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of, or intercurrent diphtheria, tetanus, pertussis disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any seizures or progressive neurological disease.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Child in care.
- •Acute disease and/or fever at the time of enrolment.
结局指标
主要结局
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
时间窗: 1 month following primary immunization (at Month 3)
Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).
次要结局
- Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)(Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization)
- Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)(1 month following primary immunization (at Month 3))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination(During the 8-day (Days 0-7) after each primary vaccine dose)
- Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)(Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization)
- Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)(1 month following primary immunization (at Month 3))
- Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)(1 month following primary immunization (at Month 3))
- Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)(Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization)
- Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)(1 month following primary immunization (at Month 3))
- Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)(Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization)
- Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)(1 month following primary immunization (at Month 3))
- Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)(Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization)
- Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)(Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination(During the 8-day (Days 0-7) period following booster vaccination)
- Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)(1 month following primary immunization (at Month 3))
- Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)(Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination(During the 8-day (Days 0-7) after each primary vaccine dose)
- Number of Subjects With Unsolicited AEs After Primary Vaccination(Within the 31-day (Days 0-30) post-primary vaccination period, across doses)
- Number of Subjects With Unsolicited AEs After Booster Vaccination(Within the 31-day (Days 0-30) post booster vaccination period)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination(During the 8-day (Days 0-7) period following booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(From study start at Month 0 up to study end at Month 15-17)
研究者
研究点 (17)
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