NCT01046097终止不适用
Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Occurrence of grade 3 unsolicited adverse events.
研究概览
简要总结
The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.
研究设计
- 研究类型
- Observational
- 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 parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- •Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
- •Filipino male or female subjects who enter the PMS at the second dose should not be less than 10 weeks of age.
- •Filipino male or female subjects who enter the PMS at the third dose should not be less than 14 weeks of age.
- •Filipino male or female subjects who enter the PMS at the booster dose (i.e. if they have received Synflorix™ in the previous dose/s outside the PMS) should not be less than 10 months of age. The time interval between the primary vaccination and booster dose should be at least 6 months. For the booster dose, subjects who received PCV-7/-13 or Synflorix™ in their primary vaccination series will be allowed to take part in the PMS.
- •Written and signed informed consent obtained from the parents/LAR(s) of the child. Where parents/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
排除标准
- •Acute disease and/or fever at the time of vaccine administration.
- •Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •History of chronic condition(s) requiring treatment such as cancer or autoimmune diseases.
- •Hypersensitivity to latex (found in syringe-tip cap and plunger).
- •Any contraindications as stated in the Prescribing Information.
结局指标
主要结局
Occurrence of grade 3 unsolicited adverse events.
时间窗: Within 31 days (Day 0 - Day 30) after each vaccination.
次要结局
- Occurrence of unsolicited adverse events.(During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.)
- Occurrence of serious adverse events.(From the Dose 1 up to study end.)
研究者
研究点 (1)
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