Continuation of the Costa Rican Epidemiologic Surveillance for Invasive Pneumococcal Disease After Introduction of the Seven Valent Vaccine Into the Universal Vaccination Program
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 4,000
- 试验地点
- 5
- 主要终点
- Impact of PCV 7 and PCV 13 on invasive pneumococcal disease in Costa Rican Children
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. Knowledge of the epidemiology of pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease usefulness of pneumococcal conjugate immunization. There is a paucity of information regarding pneumococcal disease burden in children in Latin America. Most studies are based on passive microbiology laboratory surveillance that does not capture all invasive disease, thus underestimating the true disease burden. Data from an active surveillance is available from an specific region in Costa Rica, before introduction of universal vaccination with PCV-7. On January 2009, PCV-7 was introduce into the universal vaccination program for all children born after or on September 2008 using a 3+1 regimen therefore there is a possibility to analyze the benefits of the introduction of this vaccine into the universal immunization program. The only effectiveness data from Latin America have been published from Uruguay where a significant decline in the incidence of pneumonias and meningitis was observed following the introduction of PCV-7. This was associated with an increment of serotypes 19A, 1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011, PCV-7 was changed for PCV 13. This study will provide information regarding the impact of PCV-7 and PCV-13.
详细描述
Study Objective(s):
Primary Objectives:
- Determine the population-based incidence of invasive pneumococcal disease (IPD) defined as isolation of S. pneumoniae from a normally sterile site in children 28 days to 36 months of age with signs and symptoms of disease
- Describe the serotype distribution of invasive S. pneumoniae isolates
- Compare the incidence and serotype distribution of S. pneumoniae infection in the study population before and after universal introduction of the heptavalent conjugated vaccine against S. pneumoniae.
Secondary Objectives:
- Describe the antibiotic resistance rates of invasive S. pneumoniae isolates
- Describe the serotype distribution of resistant S. pneumoniae isolates
- Assess the neurologic sequelae of pneumococcal meningitis
- Describe the bacteriology other than S. pneumoniae
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
- 28 Days 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 28 days to 36 months of age
- •Presenting to or referred to a participating healthcare facility with a measured temperature of ≥39.0 °C within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, sepsis, or other invasive pneumococcal disease, regardless of temperature
- •Subject belongs to the country specific target population for this study
- •Informed consent obtained from parent(s) or legal guardian(s) -
排除标准
- •Children younger than 28 days or older than 36 months of age at enrollment
- •Children suspected of having dengue fever as determined by local standard of care(i.e., platelet count, tourniquet test) -
结局指标
主要结局
Impact of PCV 7 and PCV 13 on invasive pneumococcal disease in Costa Rican Children
时间窗: 24 months
次要结局
- Assess the neurologic sequelae of pneumococcal meningitis(30 months)
- Describe the bacteriology other than S. pneumoniae(24 months)
- Describe the serotype distribution of resistant S. pneumoniae isolates(24 months)
- Describe serotype distribution, antimicrobial susceptibility, neurological sequelae in children with meningitis and describe bacteriology other than S. pneumoniae(30 months)
- Describe the antibiotic resistant rates of invasive S. pneumoniae isolates(24 months)