Post-marketing Surveillance (PMS) of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) -16/18 Vaccine, Cervarix™ When Administered to Healthy Females According to the Prescribing Information in Sri Lanka
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Occurrence of solicited local adverse events (AEs).
研究概览
简要总结
This PMS study aims to collect safety and reactogenicity data of Cervarix in the local population as per the licensing requirement of the Sri Lankan regulatory authority.
详细描述
Subjects who received one or two doses of Cervarix prior to the start of this PMS study can also be enrolled in the study. These subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study.
Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.
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 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they and/or their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- •A female aged 10 years and above at the time of the first vaccination.
- •Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject. Where subject/subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- •Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified as per the investigator's clinical judgement.
排除标准
- •Subjects with contraindication according to the locally approved PI.
- •Child in care.
- •Previous administration of more than two doses of Cervarix.
- •Previous vaccination with a HPV vaccine other than Cervarix.
- •Planned administration of another HPV vaccine other than Cervarix during the PMS study.
结局指标
主要结局
Occurrence of solicited local adverse events (AEs).
时间窗: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of solicited general AEs.
时间窗: During the 7-day period (Days 0-6) following any dose of Cervarix and overall.
Occurrence of unsolicited AEs.
时间窗: During the 30-day period (Days 0-29) following any dose of Cervarix and overall.
Occurrence of any Serious adverse events (SAEs) and SAE(s) causally related to vaccination.
时间窗: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of potential Immune-Mediated Diseases (pIMDs).
时间窗: Throughout the PMS study period (up to six months after the last dose of Cervarix).
Occurrence of Medically Significant Condition (MSCs).
时间窗: Throughout the PMS study period (up to six months after the last dose of Cervarix).
次要结局
未报告次要终点