Implementation of Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals With Pediatric Medical Care in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Occurrence of IS by passive (IMSS database) and active (RDE) surveillance
研究概览
简要总结
This is an epidemiology study designed to implement hospital-based active surveillance for intussusception (IS) in children <1 year of age and lower respiratory tract infection (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. An existing linked database of the "Instituto Mexicano del Seguro Social (IMSS)" will be used. The study described in this protocol is a pilot study, which will evaluate the methodology to be used in a later Post-Marketing Surveillance (PMS) study.
The planned epidemiology study will be conducted in IMSS hospitals and potentially use the IMSS database to re-capture potential cases of IS and fatal cases and as a source of matched case controls. The purpose of this project is to complement this data link system with an active surveillance system for IS - in order to assess the feasibility of using the IMSS data system by generating results that provide scientific validity. Such comprehensive (passive and active) surveillance systems will facilitate the post licensure safety profile evaluation of vaccines such as a vaccine against rotavirus diarrhoea.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The main aim of this pilot study is to allow for the implementation of active hospital-based surveillance for IS in children <1 year of age in IMSS hospitals with pediatric medical care, and LRTI-related post-neonatal deaths among children between 29 days and 1 year of age participating in the IMSS system. Surveillance will be conducted in each of the approximately 230 IMSS hospitals with pediatric medical care (tertiary care and secondary care hospitals), which have 40 million affiliates and an annual birth cohort of 575,000.
During the pilot phase the completeness and validity of electronic vaccination and demographic data contained in the IMSS dataset will be assessed to determine whether or not these data will be used during the actual post licensure study implementation. Study participation for database validation will include parental/guardian/legal representative interview and review of vaccination records.
Study staff at each of the approximately 230 IMSS hospitals will review medical records daily for potential cases of IS in children <1 year of age.
Medical records of potential IS cases will be reviewed to determine eligibility, in terms of IS, based on the Brighton criteria Parents/guardians/legal representative of definite IS cases will be contacted by study staff to recruit their child into the study.
After the informed consent is signed, the parental/guardian interview will be conducted.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An IS case deemed eligible for the study must meet the following criteria:
- •Subject is an IMSS affiliate
- •Subject is being treated/has been treated at one of the IMSS hospitals/medical facilities with IS during the study period.
- •Male or female child is <1 year of age at the time of diagnosis of the IS
- •Subject is diagnosed with definite IS
- •Written informed consent for definite IS cases is obtained from the parent/guardian/legal representative of the subject.
- •Only subjects who the investigator believes will meet the requirements of the protocol should be enrolled in the study.
- •A death deemed eligible for the study must meet the following criteria:
- •Subject is an IMSS affiliate
- •Death certificate is available
- •Male or female child between 29 days and 1 year of age, at the time of death
- •Post-neonatal LRTI-related death occurred during the study period
- •Written informed consent is obtained from the parent/guardian/legal representative of the subject.
- •For a child to be included in the random sample selected from the IMSS dataset must meet the following criteria:
- •Subject is an IMSS affiliate.
- •Male or female child belonging to the annual birth cohort selected for the evaluation.
- •Written informed consent is obtained from the parent/guardian/legal representative of the subject.
- •Subject did not die.
- •Subject currently lives in Mexico.
- •IS Cases Selected from IMSS Dataset must meet the following criteria:
- •Subject with an IS identified in the IMSS dataset.
- •Male or female child is <1 year of age at the time of diagnosis of the IS (patient becomes ineligible on the day of their first birthday).
- •Subject belongs to the annual birth cohort selected for the evaluation.
- •Children Selected as Controls for Matched Assessment
- •subject matched to a case by gender, hospital of birth and date of birth as described above.
排除标准
- •For a child to be included as a matched control:
- •subject is dead
- •subject is not currently living in Mexico
- •subject experienced an IS episode recorded in the IMSS database.
- •Exclusion criteria for enrollment: none
结局指标
主要结局
Occurrence of IS by passive (IMSS database) and active (RDE) surveillance
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Occurrence of LRTI-related post-neonatal deaths by passive surveillance (IMSS database) and active surveillance (RDE)
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Key demographic data (date of birth, hospital of birth, gender, and residential address) of IMSS affiliate
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Demographic data (date of birth, hospital of birth, gender, and residential address) from the electronic IMSS record of IMSS affiliate
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Demographic data (date of birth, hospital of birth, gender, and residential address) collected from parent/guardian/legal representative/guardian interview
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Vaccination history (DTP) from electronic IMSS dataset of IMSS affiliate
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Vaccination history (DTP) from EPI cards of IMSS affiliate.
时间窗: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
次要结局
未报告次要终点