NCT00473668已完成3 期
Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
研究概览
简要总结
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian 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.
- •Administration of one dose of hepatitis B vaccine at birth
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period with the exception of OPV.
- •Chronic administration (defined as more than 14 days) 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 30 days before the administration of the first vaccine dose, (with the exception of OPV).
- •Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- •Hepatitis B vaccine received after the first week of life.
- •Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
- •History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B 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.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
结局指标
主要结局
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens
时间窗: At Month 3
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
次要结局
- Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)(At Month 3)
- Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens(At Month 3)
- Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen(At Month 3)
- Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen(At Month 3)
- Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen(At Month 3)
- Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens(At Month 3)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period post-vaccination)
- Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off(At Month 3)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period post-vaccination)
- Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens(At Month 3)
- Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs)(At Month 3)
- Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen(At Month 3)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Day 0-3) follow-up period post-vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (Day 0-Month 3))
研究者
研究点 (4)
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