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Trial record 82 of 433 for:    OTITIS

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

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ClinicalTrials.gov Identifier: NCT02567747
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Otitis Media Pneumonia Other: Data collection

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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 : October 1, 2015
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All eligible subjects (aggregated) captured by the selected national databases in Columbia.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567747


Locations
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Colombia
GSK Investigational Site
Bogota, Colombia
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02567747     History of Changes
Other Study ID Numbers: 203127
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GlaxoSmithKline:
Colombia
otitis
Database
pneumonia
Additional relevant MeSH terms:
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Otitis
Otitis Media
Pneumococcal Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ear Diseases
Otorhinolaryngologic Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs