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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT02567747

Collaborator

(none)

Enrollment

Location

28.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Otitis Media Pneumonia	Other: Data collection

Study Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Study cohort The Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects.	Other: Data collection 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.

Arm

Intervention/Treatment

Study cohort

The Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects.

Other: Data collection

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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 [Up to 7 years : from January 2008 to December 2014]
Morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata.
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 [Up to 7 years : from January 2008 to December 2014]
morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata
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 [Up to 7 years : from January 2008 to December 2014]
* 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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).