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Trial record 1 of 1 for:    NCT00428051
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Colombia Epidemiologic Surveillance Study (LEAP II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428051
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 29, 2007
Last Update Posted : October 27, 2011
Information provided by (Responsible Party):

Tracking Information
First Submitted Date January 25, 2007
First Posted Date January 29, 2007
Last Update Posted Date October 27, 2011
Study Start Date September 2006
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2010)
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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00428051 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Colombia Epidemiologic Surveillance Study
Official Title Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Cerebral Spinal Fluid Pleural Fluid S. pneumoniae isolates
Sampling Method Probability Sample
Study Population Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria
  • Pneumonia
  • Meningitis
  • Bacteremia
  • Sepsis
Intervention Other: Surveillance
No study drug, only interventions are blood draws and Chest X-rays
Study Groups/Cohorts All eligible patients
Intervention: Other: Surveillance
Publications * Benavides JA, Ovalle OO, Salvador GR, Gray S, Isaacman D, Rodgers GL. Population-based surveillance for invasive pneumococcal disease and pneumonia in infants and young children in Bogotá, Colombia. Vaccine. 2012 Aug 31;30(40):5886-92. doi: 10.1016/j.vaccine.2012.03.054. Epub 2012 Apr 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 26, 2011)
Original Enrollment Not Provided
Actual Study Completion Date October 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages up to 36 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Colombia,   Costa Rica
Removed Location Countries Mexico
Administrative Information
NCT Number NCT00428051
Other Study ID Numbers 0887X1-900
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date October 2011