Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 756
- 试验地点
- 8
- 主要终点
- Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
研究概览
简要总结
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)
详细描述
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
- Double (Care Provider, Outcomes Assessor)
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
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
- •Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
- •Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study
- •History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- •Acute disease at the time of enrolment.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
研究组 & 干预措施
Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
干预措施: Polio Sabin (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
干预措施: Synflorix (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
干预措施: Tritanrix-HepB (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
干预措施: Hiberix (Biological)
Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
干预措施: Tritanrix-HepB (Biological)
Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
干预措施: Hiberix (Biological)
Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age.
干预措施: Prevenar (Wyeth) (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
干预措施: Synflorix (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
干预措施: Tritanrix-HepB (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
干预措施: Hiberix (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age.
干预措施: Poliorix (Biological)
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.
干预措施: Tritanrix-HepB (Biological)
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.
干预措施: Hiberix (Biological)
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.
干预措施: Poliorix (Biological)
Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group
Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age.
干预措施: Prevenar (Wyeth) (Biological)
Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group
Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age.
干预措施: Polio Sabin (Biological)
结局指标
主要结局
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
时间窗: Within the 4-day (Days 0-3) period after booster vaccination
Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever \> 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.
次要结局
- Antibody Concentrations to Protein D (Anti-PD)(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Anti-Bordetella Pertussis (BPT) Antibody Concentrations(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) period after booster vaccination)
- Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Anti-polio Type 1, 2 and 3 Antibody Titers(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within the 4-day (Days 0-3) period after booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the active phase of the study (Month 0 to Month 1))
- Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Any and Grade 3 Solicited General Symptoms(Within the 4-day (Days 0-3) period after booster vaccination)
- Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)(One month after booster vaccination (Month 1))
- Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))
- Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off(Prior to (Month 0) and one month after booster vaccination (Month 1))