Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,091
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)
研究概览
简要总结
This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects aged between and including, 10 to 25 years at the time of the first vaccination.
- •Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the PMS.
- •Written informed consent obtained from the subject or the subjects' parent/ guardian.
- •Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement.
- •Subjects with no contraindication according to the local approved prescribing information.
- •No previous administration of an HPV vaccine other than Cervarix®.
- •No previous administration of more than two doses of Cervarix®.
- •No planned administration of an HPV vaccine other than Cervarix® during the PMS
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
时间窗: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
时间窗: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects With Medically Significant Conditions.
时间窗: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)
MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
次要结局
未报告次要终点