A Case-Control Study to Assess the Effectiveness of Rotarix Vaccine (RV1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Matched VE Participants in the Minimum Age Model
研究概览
简要总结
To determine the effectiveness of rotavirus vaccines, active surveillance will be conducted at two sites, Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio and the Medical University of South Carolina (MUSC) in Charleston, South Carolina.
Children born on or after April 1, 2006 presenting to CCHMC as an inpatient or for a short-stay or Emergency Department (ED) visit with acute gastroenteritis (AGE) and/or fever will be approached for enrollment. Children will be eligible if they have vomiting and/or diarrhea less than or equal to 10 days duration. Data including demographic information, illness characteristics and socio-economic status will be collected from each patient. A sample of the patient's stool will be collected within 14 days of the onset of symptoms. Stool specimens will be tested for rotavirus antigen by Rotaclone at CCHMC. All rotavirus positive stool specimens will be typed for common G and P serotypes. Using the children identified with rotavirus as our cases and the children who were rotavirus negative as our controls, we will conduct a case control study to assess the effectiveness of rotavirus vaccines, in particular Rotarix.
详细描述
A case-control design will be utilized to assess the effectiveness of RV1 in preventing rotavirus-associated hospitalizations and Emergency Department (ED) visits using cases and controls from the 2009-2012 rotavirus seasons. Vaccine exposure among cases will be compared to vaccine exposure among controls. There will be one case group and one control group.
Cases will be obtained from children who are enrolled in active surveillance for acute gastroenteritis being conducted at the two initial surveillance sites. These sites include: Cincinnati Children's Hospital Medical Center (2009-2012) and the Medical University of South Carolina (2009-2012). Cases and controls will be identified retrospectively for the 2008-2011 seasons and prospectively through active surveillance for the 2011-2012 season. The active surveillance programs conduct prospective surveillance for hospitalizations and ED visits due to AGE (acute gastroenteritis) in children < 6 years of age. Even though Rotarix was commercially available on January 1, 2008, the actual date that RV1 was initially used varied across sites. The date that Rotarix was initially used will be determined for each site through examination of the data. Children with laboratory-confirmed rotavirus infection (bulk stool sample positive for rotavirus using a rotavirus EIA) will be included as a case if they were born 2 months prior to the initial date of Rotarix availability at each site. The vaccine record for each case will be obtained to determine the vaccine status of the child.
Controls will be children born 2 months prior to the availability of Rotarix at each site who were enrolled in the active surveillance program at either site and who tested negative for rotavirus. Children who have been previously hospitalized for diarrhea, who have a sibling enrolled in the study, or who have recently moved into the study area (and might not have been eligible for the vaccine) will be excluded.
Laboratory Testing
For children enrolled in the active surveillance program bulk stool specimens are obtained within 14 days of the visit for AGE symptoms and are tested using Rotaclone, a commercial enzyme immunoassay (Meridian Bioscience, Inc) at CCHMC. Children with a positive test for rotavirus are eligible to be cases and children with a negative test for rotavirus are eligible for controls. Specimens positive by EIA for rotavirus will have G and P genotyping done at CCHMC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the child is < 6 years of age
- •for the vaccine effectiveness analysis using the Minimum Age Model, the child was included if born on or after 8/10/2008 at MUSC and on or after 12/1/2008 at CCHMC.
- •for the vaccine effectiveness analysis using the Maximum Age Model, the child was included if >=8 months of age.
- •the child is being evaluated at Cincinnati Children's Hospital Medical Center (CCHMC) or the Medical University of South Carolina (MUSC) as an inpatient, short-stay visit or in the emergency department
- •the child has acute gastroenteritis defined as
- •diarrhea (>3 loose stools in a 24 hour period) OR
- •-vomiting (>1 episodes in a 24 hour period)
- •the child's illness is of <10 days duration
- •written consent is obtained from the child's parent or legal guardian
排除标准
- •the child is >6 year of age
- •the child had onset of fever or gastroenteritis symptoms > 10 days prior to admission
- •the child has a non-infectious or other identifiable cause of their symptoms, such as head trauma, pyelonephritis, pyloric stenosis, or prolonged coughing
- •the child is immunocompromised
- •there is no parent or guardian available
- •the parent/guardian is non-English speaking
- •previously enrolled for the same episode of gastroenteritis
- •for the vaccine effectiveness analysis using the Minimum Age Model, the child was excluded if born prior to 8/10/2008 at MUSC and prior to 12/1/2008 at CCHMC.
- •for the vaccine effectiveness analysis using the Maximum Age Model, the child was excluded if <8 months of age.
研究组 & 干预措施
Rotavirus Positive Cases
This group includes all participants who submitted a stool specimen that tested positive for Rotavirus.
Rotavirus Negative Controls
This group includes all participants who submitted a stool specimen that tested negative for Rotavirus.
结局指标
主要结局
Matched VE Participants in the Minimum Age Model
时间窗: 14 days from the date of enrollment
RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 52 days of age. The recommend age for the first dose is 42 days, but children are considered vaccinated if they receive that dose within 4 days of the recommended age, which lowers the acceptable minimum age to 38 days. We added 14 days to enable them to mount an immune response to arrive at a minimum age of 52 days. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.
Vaccine Effectiveness of RV1 in the Minmum Age Model
时间窗: 14 days from the date of enrollment
RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were age-eligible to receive at least the first dose of RV1 vaccine. Only valid RV1 vaccinations were considered. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses. VE was estimated as (1 - exposure odds ratio) x 100.
Matched VE Participants in the Maximum Age Model
时间窗: 14 days from the date of enrollment
RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 8 months of age, the maximum recommend age for completion of 2 doses of RV1. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.
Vaccine Effectiveness of RV1 in the Maximum Age Model
时间窗: 14 days from the date of enrollment
RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were greater than or equal to 8 months of age, the maximum recommended age for completion of two doses of RV1 vaccine. Only valid RV1 vaccinations were considered. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses. VE was estimated as (1 - exposure odds ratio) x 100.
次要结局
未报告次要终点