Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 6
- 主要终点
- Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
研究概览
简要总结
The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.
详细描述
This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.
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
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must satisfy the following criteria at study entry:
- •A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Born after 36 to 42 weeks of gestation.
- •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.
- •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.
排除标准
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
- •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 .
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
- •History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration
研究组 & 干预措施
GSK2197870A Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
干预措施: Menitorix™ (Biological)
GSK2197870A Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
干预措施: GSK2197870A (Biological)
GSK2197870A Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
干预措施: Prevenar™ (Biological)
Pediacel Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
干预措施: Prevenar™ (Biological)
Pediacel Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
干预措施: Menitorix™ (Biological)
Pediacel Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
干预措施: Pediacel™ (Biological)
Pediacel Group
Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
干预措施: Menjugate™ (Biological)
结局指标
主要结局
Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
时间窗: At Month 3
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
时间窗: At Month 2 and Month 3.
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
次要结局
- Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.(At Month 2 and Month 3.)
- Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.(At Month 3)
- Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.(At Month 3.)
- Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.(At Month 3.)
- Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).(At Month 3.)
- Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.(At Month 3)
- Concentrations for Anti-PRP.(At Month 10 and Month 11.)
- Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.(At Month 10 and Month 11.)
- Titers for rSBA-MenC.(At Month 10 and Month 11.)
- Concentrations for Anti-PSC.(At Month 10 and Month 11.)
- Concentrations for Anti-T and Anti-D.(At Month 10.)
- Concentrations for Anti-PT, Anti-FHA and Anti-PRN.(At Month 10.)
- Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.(At Month 10.)
- Number of Subjects Reporting Any Solicited Local Symptoms.(During the 8-day (Days 0-7))
- Titers for Anti-polio 1, 2 and 3.(At Month 10.)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs).(During the entire study period (Month 0 to Month 11))
- Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.(At Month 10.)
- Number of Subjects With a Booster Response to Anti-PRP Antibodies.(At Month 11)
- Number of Seropositive Subjects Against rSBA-MenC.(At Month 10 and Month 11.)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).(Within the 31-day (Days 0-30) follow up period after vaccination.)
- Concentrations for Anti-PNE Serotypes.(At Month 3.)
- Number of Seroprotected Subjects for Anti-PRP.(At Month 10 and Month 11.)
- Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.(At Month 10.)
- Number of Subjects With a Booster Response to rSBA-MenC Antibodies.(At Month 11)
- Number of Subjects With a Booster Response to Anti-PSC Antibodies.(At Month 11)
- Number of Subjects Reporting Any Solicited General Symptoms.(During the 8-day (Days 0-7))