Status:
COMPLETED
Implementing Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals in Mexico
Lead Sponsor:
GlaxoSmithKline
Conditions:
Intussusception
LRTI-related Post Neonatal Deaths
Eligibility:
All Genders
Up to 1 years
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 ...
Detailed Description
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-rel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00436358
Start Date
April 1 2007
End Date
January 1 2008
Last Update
January 31 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Mexico City, Mexico, 06720