Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,437
- 试验地点
- 63
- 主要终点
- Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)
研究概览
简要总结
The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.
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 = NCT00334334).
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
- None
入排标准
- 年龄范围
- 11 Months 至 18 Months（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, 11-18 months of age at the time of the booster vaccination.
- •A male or female who previously participated in study 107005 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.
- •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 (one month after the booster dose of study vaccines).
- •Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study
- •History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease.
- •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 (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).
研究组 & 干预措施
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
干预措施: Pneumococcal conjugate vaccine GSK1024850A (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
干预措施: Infanrix IPV Hib (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
干预措施: Pneumococcal conjugate vaccine GSK1024850A (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
干预措施: Infanrix IPV Hib (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Pneumococcal conjugate vaccine GSK1024850A (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
干预措施: NeisVac-C (Biological)
Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Menitorix (Biological)
Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Infanrix IPV (Biological)
Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Infanrix penta (Biological)
Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Prevenar (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Menitorix (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Infanrix IPV (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
干预措施: Infanrix penta (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
干预措施: Infanrix hexa (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
干预措施: Meningitec (Biological)
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
干预措施: Infanrix hexa (Biological)
结局指标
主要结局
Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)
时间窗: During the 4-day (Day 0-3) period after the booster vaccination
Fever was measured as rectal temperature.
次要结局
- Number of Subjects Reporting Solicited Local Symptoms(During the 4-day (Day 0-3) period after the booster vaccination)
- Number of Subjects Reporting Solicited General Symptoms(During the 4-day (Day 0-3) period after the booster vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAE)(From the beginning of the study up to the end of the extended 6-month safety follow-up period)
- Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 31-day (Day 0-30) period after the booster vaccination)
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the booster administration)
- Number of Subjects Reporting Serious Adverse Events (SAE)(During the 31-day (Day 0-30) period after the booster vaccination)