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

Completed

• Conditions: Acute Otitis Media; Pneumonia
• Interventions: Other: Data collection

• Registration Number: NCT02567747
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-28
• Study Start: 2015-10-01
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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).

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Exclusion Criteria

• Not applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	Data collection	The Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇴 Bogota, Colombia