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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00436358
First received: February 16, 2007
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Intussusception
LRTI-related Post Neonatal Deaths
Other: Not applicable: none

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Implementation of Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals With Pediatric Medical Care in Mexico

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 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 [ 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. ]
  • Vaccination history (DTP) from EPI cards 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. ]

Enrollment: 134
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
IS case deemed children
Other: Not applicable: none
Please refer to the detailed description section
Other Name: Not applicable: none
Group B
LRTI-related post-neonatal deaths deemed Children
Other: Not applicable: none
Please refer to the detailed description section
Other Name: Not applicable: none
Group C
A random sample of children from an annual birth cohort within the electronic IMSS dataset
Other: Not applicable: none
Please refer to the detailed description section
Other Name: Not applicable: none
Group D
All children from a single annual birth cohort with IS identified in their electronic IMSS data
Other: Not applicable: none
Please refer to the detailed description section
Other Name: Not applicable: none
Group E
A sample of children from the electronic IMSS dataset selected to match the selected IS cases on age, gender, and hospital of birth.
Other: Not applicable: none
Please refer to the detailed description section
Other Name: Not applicable: none

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

IMSS hospitals with pediatric medical care in Mexico

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436358

Locations
Mexico
GSK Investigational Site
Mexico DF, Mexico, 06720
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00436358     History of Changes
Other Study ID Numbers: 106175
Study First Received: February 16, 2007
Last Updated: January 27, 2011
Health Authority: Mexico: Instituto Mexicano del Seguro Social (IMSS)

Keywords provided by GlaxoSmithKline:
Mexico
Intussusception
Epidemiology

Additional relevant MeSH terms:
Intussusception
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014