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The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the introduction of vaccination against pneumococcal disease within the Universal Mass Vaccination (UMV) in Colombia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | The Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data will be collected retrospectively for cases identified through RIPS*/ DANE** from 2008 until 2014 and through PAI*** from 2009 until 2014. *Registro Individual de Prestación de Servicios de Salud (RIPS) database (Health Service Provider Individual Registration Database), Columbia. **Departamento Administrativo Nacional de EstadÃstica (DANE) database (The National Administrative Department of Statistics database), Columbia. ***Programa Ampliado de Immunizaciones (PAI) database (National Immunization Program database), Columbia. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of reported cases of AOM in children below 5 years of age, in post-vaccination period compared to pre-vaccination period of PCV vaccination in UMV | Up to 7 years : from January 2008 to December 2014 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of reported cases of AOM in children by morbidity, age group, and department in children in post-vaccination period compared to pre-vaccination period of PCV vaccination | Morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata. | Up to 7 years : from January 2008 to December 2014 |
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Inclusion Criteria:
Exclusion Criteria:
• Not applicable
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All eligible subjects (aggregated) captured by the selected national databases in Columbia.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bogotá | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32966144 | Derived | Carrasquilla G, Porras-Ramirez A, Martinez S, DeAntonio R, Devadiga R, Talarico C, Caceres DC, Castrejon MM, Juliao P. Trends in all-cause pneumonia and otitis media in children aged <2 years following pneumococcal conjugate vaccine introduction in Colombia. Hum Vaccin Immunother. 2021 Apr 3;17(4):1173-1180. doi: 10.1080/21645515.2020.1805990. Epub 2020 Sep 23. |
| Label | URL |
|---|---|
| Results for study 203127 can be found on the GSK Clinical Study Register | View source |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D011014 | Pneumonia |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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|
| Occurrence of reported cases of pneumonia and acute respiratory infections, overall and by morbidity, age groups, and department in children below 5 years of age before and after implementation of PCV vaccination into the UMV | morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata | Up to 7 years : from January 2008 to December 2014 |
| Occurrence of reported deaths due to pneumonia and acute respiratory infections by age group (0-24 months and 25-59 months), department and overall in children below 5 years of age before and after implementation of PCV vaccination into the UMV | Up to 7 years : from January 2008 to December 2014 |
| Occurrence of AOM related health care resources used and costs* before and after implementation of PCV vaccination into UMV by age group (0-24 months and 25-59 months) and overall | * Cost calculation (e.g. medical procedures** , physician visits [outpatient/inpatient and length of stay]) will be extracted from Medical Procedure Cost Manual from the MOH for this analysis: http://www.fasecolda.com/index.php/ramos/soat/tarifas-y-coberturas/manual-tarifario-de-salud/. ** Tympanostomies/myringotomies, myringotomies with insertion of ventilation tubes, etc. | Up to 7 years : from January 2008 to December 2014 |
| Total number of doses (complete or partial) of PCV vaccination administered in infants <1year of age after its introduction into the UMV program in Colombia. | Up to 7 years : from January 2008 to December 2014 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |