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

NCT ID: NCT02567747

Last Updated: 2019-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Otitis Media Pneumonia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study cohort

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Data collection

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type DERIVED
PMID: 32966144 (View on PubMed)

Other Identifiers

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203127

Identifier Type: -

Identifier Source: org_study_id

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