Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island: Active Hospital-Based Surveillance, Serotype Surveillance and a Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lifespan
- 入组人数
- 803
- 试验地点
- 1
- 主要终点
- Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations
研究概览
简要总结
The goals of this study are to see what effects the introduction of RV5(RotaTeq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. The investigators will use cases of rotavirus gastroenteritis identified on the wards at Hasbro Children's Hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. The investigators plan to assess rotavirus vaccine coverage in Rhode Island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island. Finally using the state child health database, KIDSNET the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.
详细描述
The goals of this study, conducted after the introduction of RV5 (RotaTeq) vaccine in the community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions, 2) to assess rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in Rhode Island and 3) to investigate risk factors for non-receipt of rotavirus vaccine to inform educational efforts for parents and providers, and 4) to characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine to determine if serotype replacement is occurring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rotavirus gastroenteritis requiring hospitalization
- •immunocompetent
- •born after April 15, 2006
- •greater than 2 months of age on the day of admission
排除标准
- •rotavirus vaccine contraindicated for that child based on ACIP/AAP recommendations
- •an immunization record cannot be obtained through the KIDSNET database
结局指标
主要结局
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations
时间窗: 2007-2009
Rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions
次要结局
- Assess rotavirus vaccine coverage(2007-2009)
- Vaccine use outside the recommended age limits(2007-2009)
- Risk factors for non-receipt of rotavirus vaccine(2007-2009)
- Characterize the strains of rotavirus circulating in the community(2002-2009)
研究者
Penelope H. Dennehy
Principal Investigator
Lifespan