NCT00679796已完成不适用
The Effectiveness of Varicella Vaccination in Children in Germany
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,012
- 试验地点
- 1
- 主要终点
- Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children.
研究概览
简要总结
This study is undertaken to evaluate the effectiveness of currently licensed varicella vaccines under conditions of routine use in a setting where varicella vaccine is included in the childhood immunization calendar.
详细描述
Observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the Munich area.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female child at least one year of age, born on or after July 1
- •Residence in Germany
- •At least one previous well-child visit to the practice
- •Written informed consent obtained from parents/guardians of the subject as per local requirements.
- •Specific inclusion criterion for cases:
- •Suspected primary varicella disease (i.e. chickenpox) at the time of study entry
排除标准
- •Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are:
- •History of hypersensitivity to any of the components of the vaccines
- •Congenital or acquired immunodeficiency
- •Treatment with immunosuppressive therapy
- •HIV-infected patients, when CD4 < 25% of total lymphocytes
- •Previous history of chickenpox by physician record or parental report.
- •Lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet).
结局指标
主要结局
Occurrence of PCR-confirmed varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children.
次要结局
- Occurrence of PCR-confirmed severe varicella cases in children administered one dose of Varilrix™ (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of PCR-confirmed severe varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of clinical varicella cases in children administered two doses of commercially-available varicella vaccine (≥ 28 days after receipt of the second dose of vaccine) or in unvaccinated children
- Occurrence of PCR-confirmed varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children
- Occurrence of clinical varicella cases in children administered one dose of commercially-available varicella vaccine (≥ 28 days after receipt of vaccine) or in unvaccinated children
研究者
研究点 (1)
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