Assessment of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information in Korea.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,388
- 试验地点
- 1
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.
详细描述
Adults and previously vaccinated children aged ≥6 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 6 months to less than (<) 9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local PI in Korea.
Fluarix Tetra may be administered to pregnant women/lactating women as per PI, if there is a clear need. Pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.
- •Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject's parent(s)/Legally acceptable Representative(s) [LAR(s)].
排除标准
- •Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.
- •Hypersensitivity reaction to Fluarix Tetra.
- •History of hypersensitivity reaction to Influenza vaccine.
- •History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination.
- •Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician.
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs)
时间窗: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.
Number of Participants With Unexpected Adverse Events (AEs)
时间窗: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.
Number of Participants With Expected Adverse Events (AEs)
时间窗: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.
次要结局
未报告次要终点