Bacteremia, Meningitis, Pneumonia, Sepsis
Conditions
Keywords
Epidemiology, Surveillance, Streptococcal Pneumonia
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 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.
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.
Interventions
OTHERSurveillance
No study drug, only interventions are blood draws and Chest X-rays
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
28 Days to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 2 years |
Countries
Brazil, Colombia, Costa Rica
Outcome results
None listed