Trials / Terminated
TerminatedNCT00428051
Colombia Epidemiologic Surveillance Study
Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 32,867 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 28 Days – 36 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Surveillance | No study drug, only interventions are blood draws and Chest X-rays |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2011-02-01
- Completion
- 2011-10-01
- First posted
- 2007-01-29
- Last updated
- 2011-10-27
Locations
3 sites across 3 countries: Brazil, Colombia, Costa Rica
Source: ClinicalTrials.gov record NCT00428051. Inclusion in this directory is not an endorsement.