Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age

GlaxoSmithKline1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Otitis Media Pneumonia

Interventions

Data collectionOTHER

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 Estadística (DANE) database (The National Administrative Department of Statistics database), Columbia. \*\*\*Programa Ampliado de Immunizaciones (PAI) database (National Immunization Program database), Columbia.

Eligibility

Sex: ALLMax age: 59 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged less than five years with record of acute otitis media (with ICD-10 codes: H65 to H66) AND/OR. * Children aged less than five years with record of pneumonia (with ICD-10 codes: J13 to J18) AND/OR. * Children aged less than five years with any ICD-10 codes for respiratory diseases (J00-J99). Exclusion Criteria: • Not applicable

Locations (1)

GSK Investigational Site

Bogotá, Colombia

Outcomes

Primary Outcomes

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

Time frame: Up to 7 years : from January 2008 to December 2014

Secondary Outcomes

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.

Time frame: Up to 7 years : from January 2008 to December 2014

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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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