Colombia Epidemiologic Surveillance Study

Pfizer32,867 enrolled

Overview

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 incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

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.

Study Type

OBSERVATIONAL

Enrollment

32,867

Conditions

Pneumonia Meningitis Bacteremia Sepsis

Interventions

SurveillanceOTHER

No study drug, only interventions are blood draws and Chest X-rays

Eligibility

Sex: ALLMin age: 28 DaysMax age: 36 Months

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (3)

Pfizer Investigational Site

Goiânia, Goiás, Brazil

Pfizer Investigational Site

Bogotá, Colombia

Pfizer Investigational Site

Uruca, Provincia de San José, Costa Rica

Outcomes

Primary Outcomes

Annual age specific incidence rate of invasive pneumococcal disease based on the number of identified cases from the study sites and the size of the population at risk for children 28 days to 36 months of age

Time frame: 2 years

Data from ClinicalTrials.gov

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