An Open, Multicentric, Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 and 18 Months of Age, in Healthy Infants.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,590
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Any Solicited Local and General Symptoms
研究概览
简要总结
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Weeks 至 17 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have been enrolled in the Rota-028 study.
- •A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- •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.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
排除标准
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
研究组 & 干预措施
Group A
干预措施: GSK Biologicals' combined DTPa-IPV/Hib vaccine (Biological)
结局指标
主要结局
Number of Subjects Reporting Any Solicited Local and General Symptoms
时间窗: During the 4-day (Days 0-3) post-vaccination period, across doses
Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )\], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.
次要结局
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)(During the 30-day (Days 0-29) post-vaccination period)
- Number of Subjects Reporting Large Injection Site Swelling(At Month 18, post-booster dose)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(During the entire study period)