NCT00390910已完成3 期
Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 9
- 主要终点
- Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
研究概览
简要总结
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.
This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)
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
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Weeks 至 16 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
- •A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Born after a gestation period of >27 weeks (at least 189 days).
- •If full term born, healthy subjects as established by medical history and clinical examination before entering into the study
- •If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).
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 vaccines, or planned use during the study period
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit
- •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past).
- •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, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month preceding the first dose of study vaccines or planned administration during the active phase of the study.
研究组 & 干预措施
Synflorix™ + Infanrix™ hexa Group I
Experimental
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
干预措施: Pneumococcal conjugate vaccine GSK1024850A (Biological)
Synflorix™ + Infanrix™ hexa Group II
Experimental
Mild pretem infants born after a gestation period of 31-36 weeks (217-258 days)
干预措施: Pneumococcal conjugate vaccine GSK1024850A (Biological)
Synflorix™ + Infanrix™ hexa Group III
Experimental
Infants born after a gestation period of more than 36 weeks (more than 258 days)
干预措施: Pneumococcal conjugate vaccine GSK1024850A (Biological)
Synflorix™ + Infanrix™ hexa Group III
Experimental
Infants born after a gestation period of more than 36 weeks (more than 258 days)
干预措施: Infanrix hexa (Biological)
Synflorix™ + Infanrix™ hexa Group II
Experimental
Mild pretem infants born after a gestation period of 31-36 weeks (217-258 days)
干预措施: Infanrix hexa (Biological)
Synflorix™ + Infanrix™ hexa Group I
Experimental
Very preterm infants born after a gestation period of 27-30 weeks (189-216 days)
干预措施: Infanrix hexa (Biological)
结局指标
主要结局
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
时间窗: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
次要结局
- Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Any Serious Adverse Events (SAEs)(Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).)
- Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F(One month after the 3rd vaccine dose (Month 5))
- Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Any and Grade 3 Solicited General Symptoms(Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4))
- Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4))
- Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F(One month after the 3rd vaccine dose (Month 5))
- Concentrations of Antibodies Against Protein D (Anti-PD)(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4))
- Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
- Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)(One month after the 3rd vaccine dose (Month 5))
- Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.(One month after the 3rd vaccine dose (Month 5))
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off(One month after the 3rd vaccine dose (Month 5))
研究者
研究点 (9)
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