Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 883
- 主要终点
- Number of Participants Reporting Severe Unsolicited Adverse Events
研究概览
简要总结
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female > 6 months of age at the time of the first vaccination.
- •Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
- •If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
排除标准
- •Clinical signs of acute febrile illness at the time of entry into the study.
- •Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.
研究组 & 干预措施
Unprimed, > 6 to < 72 Months
Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
干预措施: FluarixTM (Biological)
Unprimed, ≥ 72 to < 108 Months
Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
干预措施: FluarixTM (Biological)
Primed, > 6 to < 72 Months
Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
干预措施: FluarixTM (Biological)
Primed, ≥ 72 to < 108 Months
Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
干预措施: FluarixTM (Biological)
Primed, ≥ 108 to < 216 Months
Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
干预措施: FluarixTM (Biological)
Primed, ≥ 216 Months
Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
干预措施: FluarixTM (Biological)
结局指标
主要结局
Number of Participants Reporting Severe Unsolicited Adverse Events
时间窗: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
An Adverse Event is 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. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities
次要结局
- Number of Participant Reporting Unsolicited Adverse Events.(During the 21-day follow-up period (Day 0 to Day 20) after vaccination)
- Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.(During the 4-day follow up (Day 0 to 3) after vaccination.)
- Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.(During the 4-day follow up (Day 0 to 3) after vaccination.)
- Number of Participants Reporting Serious Adverse Events (SAE).(Within 1 month following vaccination)