Status:

TERMINATED

Colombia Epidemiologic Surveillance Study

Lead Sponsor:

Pfizer

Conditions:

Pneumonia

Meningitis

Eligibility:

All Genders

28-36 years

Brief Summary

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidenc...

Detailed Description

The study was stopped based on a decision to include PCV 10 in the National Immunization Program in Colombia. The study was designed to measure the impact of PCV 7 and 13 and is no longer feasible.

Eligibility Criteria

Inclusion

  • Children 28 days to 36 months of age
  • Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease

Exclusion

  • Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection

Key Trial Info

Start Date :

September 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

32867 Patients enrolled

Trial Details

Trial ID

NCT00428051

Start Date

September 1 2006

End Date

October 1 2011

Last Update

October 27 2011

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Pfizer Investigational Site

Goiânia, Goiás, Brazil, 074065-050

2

Pfizer Investigational Site

Bogotá, Colombia

3

Pfizer Investigational Site

Uruca, Provincia de San José, Costa Rica, 607-1159

Colombia Epidemiologic Surveillance Study | DecenTrialz