Clinical Trial: Implementing Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals in Mexico

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Implementation of Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals With Pediatric Medical Care in Mexico

Brief Summary:

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.


Detailed Summary:

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.

Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged.

A central Information Coordinator (IMSS staff member) will perform monthly revie
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Occurrence of IS by passive (IMSS database) and active (RDE) surveillance [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Approx 3 months to initiate the active surveillance systems in approx 2

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: GlaxoSmithKline

    Dates:
    Date Received: February 16, 2007
    Date Started: April 2007
    Date Completion:
    Last Updated: January 27, 2011
    Last Verified: January 2011