Post-marketing Surveillance (PMS) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Conjugate Vaccine (Synflorix™) When Administered to Healthy Infants and Children 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 Serious Adverse Events (SAEs)
研究概览
简要总结
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
详细描述
The participating physicians (investigators) will be asked to enrol only those subjects to whom they administer Synflorix™ in the course of their normal clinical practice according to the locally approved Prescribing Information.
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
- 6 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- •Infants aged 6 weeks and above and children.
- •Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- •Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected.
排除标准
- •Subjects with contraindications according to the locally approved PI.
- •Child in care.
- •Previous administration of three doses of Synflorix™.
- •Previous vaccination with a pneumococcal vaccine other than Synflorix™.
- •Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study.
结局指标
主要结局
Occurrence of Serious Adverse Events (SAEs)
时间窗: Throughout the PMS study period, starting at Dose 1 (Visit 1) and ending 31 days (Day 0 to Day 30) after the last dose of Synflorix™ for each subject in the PMS study
Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs)
时间窗: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall
Occurrence of unsolicited AEs
时间窗: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall
次要结局
未报告次要终点