Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 457
- 试验地点
- 9
- 主要终点
- The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine
研究概览
简要总结
Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program.
The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.
详细描述
open label, one group Purposive sampling of hospitalized children ≤14 years of age with confirmed IPD
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 14 years old or less.
- •Hospitalized in a participating healthcare facility with an IPD.
- •IPD will be confirmed by isolation of S. pneumoniae from a sterile body site.
排除标准
- •Children > 14 years of age
- •Unconfirmed IPD
结局指标
主要结局
The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine
时间窗: yearly
次要结局
- Serotype distribution of resistant S. pneumoniae isolates(yearly)
- Serotype distribution of IPD between immunized and non immunized children ≤14 years of age(yearly)
- Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin(yearly)