Multicentric, Surveillance Study to Monitor Safety of GSK Biologicals' Purified Meningococcal Polysaccharide Vaccine of Serogroups ACWY in 3,000 Filipino Subjects Aged Above 2 Years When Administered According to the Prescribing Information.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 8
- 主要终点
- Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events
研究概览
简要总结
GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.
详细描述
All subjects will receive a single dose of GSK Biologicals' Mencevax ACWY vaccine according to the prescribing information. Subjects will be stratified into the following age groups:
2 to 5 years 6 to 17 years > 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol.
- •A Filipino male or female > 2 years of age at the time of the first vaccination.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Written informed consent obtained from the subject and/or from the parent/ guardian of the subject.
- •Exclusion criteria:
- •Subjects suffering from acute severe febrile illness.
- •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.
- •Pregnant or lactating female.
- •Female planning to become pregnant.
- •History of chronic alcohol consumption and/or intravenous drug abuse.
- •Any contraindications as stated on the Prescribing Information.
排除标准
- 未提供
研究组 & 干预措施
Group A
干预措施: Mencevax ACWY (Biological)
结局指标
主要结局
Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events
时间窗: During the 31-day (Days 0-30) post-vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.
次要结局
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period)
- Number of Subjects With Any and Grade 3 Solicited Local Adverse Events(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Month 1))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)