NCT00985751已完成2 期
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 11
- 主要终点
- Number of Subjects With Fever > 40.0°C (Rectal Temperature)
研究概览
简要总结
This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- •Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
- •Written informed consent obtained from the parents/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •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 within six months prior to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
- •Previous vaccination against S. pneumoniae since birth.
- •History of any hypersensitivity reaction following any previous vaccination.
- •Eczema and any history of allergy
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or any chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
- •Child in care.
结局指标
主要结局
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
时间窗: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
次要结局
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) follow-up period after the booster dose)
- Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes(One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7))
- Antibody Concentrations to Protein D (Anti-PD)(One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7))
- Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity(One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7))
- Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations(One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7))
- Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations(One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7))
研究者
研究点 (11)
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