Vaccine Effectiveness of RV1 in a Naïve Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 试验地点
- 3
- 主要终点
- Matched VE Participants
研究概览
简要总结
Rotavirus (RV) is the leading cause of severe gastroenteritis (GE) in young children. The cumulative risk of GE hospitalizations and hospital stays of < 24 hours is 1/25, which would amount to 13,600 Canadian children < 5 years. The incidence of nosocomial RV infections is an average of 8/10,000 patient-days in children < 5 years. An immunization program with a live-attenuated monovalent oral RV vaccine (RV1 - Rotarix® from GSK) will be implemented, free of charge, in the Province of Quebec in November 2011. To provide an accurate portrait of the disease and give critical information to the public health agencies as they struggle to control costs, we aim to evaluate the accuracy of surveillance for RV and other diseases with similar characteristics; estimate selection bias in passive laboratory-based surveillance; and estimate the agreement between surveillance time-series created from passive and active surveillance data sources.
详细描述
In November 2011, Quebec implemented a publicly-funded RV1 vaccination program with its routine administration at 2 and 4 months of age. From February 1, 2012 - May 31, 2014, we conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children's Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke. Active surveillance was approved by Research Ethics Boards at each hospital.
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
- 8 Weeks 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child less than 3 years old
- •Acute gastroenteritis (within 7 days of hospital visit)
- •able to provide a stool specimen for RV ELISA testing
- •Rotavirus positive
- •Visited the ED or admitted for a non-rotavirus gastroenteritis
- •Visited the ED or admitted for acute respiratory infections without gastroenteritis symptoms
排除标准
- •Immunocompromised children
- •Prior history of intussusception
- •Admission to NICU between 6 to 15 weeks of life, for >6 weeks
- •Child less than 56 days of life (8 weeks)
- •Child vaccinated with Rotateq (Merck)
结局指标
主要结局
Matched VE Participants
时间窗: From February 1, 2012 to May 31, 2014
RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) \<15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively. We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded.
次要结局
未报告次要终点
研究者
Caroline Quach-Thanh
MD, MSc, FRCPC
McGill University Health Centre/Research Institute of the McGill University Health Centre