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Completed

NCT Number: NCT02567747

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

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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Key information

Conditions

Acute Otitis Media Ear Diseases Infections Lung Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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

  3. 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

  4. 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

    Time frame: 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.

  5. 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.

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2015
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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