Last updated: 11/03/2018 08:43:33

Implementing hospital-based active surveillance procedures for vaccine safety monitoring at IMSS hospitals in Mexico

GSK study ID
106175
Clinicaltrials.gov ID
NCT00436358
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Implementation of hospital-based active surveillance procedures for vaccine safety monitoring at IMSS hospitals with pediatric medical care in Mexico
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of IS by passive (IMSS database) and active (RDE) surveillance

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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.

Timeframe: 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.

Secondary outcomes:
Not applicable
Interventions:
  • Other: Not applicable: none
    • Enrollment:
    134
    Primary completion date:
    2008-07-01
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Intussusception, LRTI-related post neonatal deaths
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to January 2008
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable N/A - 1 years
    Accepts healthy volunteers
    No
    • An IS case deemed eligible for the study must meet the following criteria:
    • Subject is an IMSS affiliate
    • For a child to be included as a matched control:
    • subject is dead
    Inclusion and exclusion criteria
    Inclusion criteria:

      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.
    Exclusion criteria:

      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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Mexico DF, Mexico, 06720
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2008-07-01
    Actual study completion date
    2008-07-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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