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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567747
• Other study ID #: 203127
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: February 23, 2018

Study information

• Verified date: June 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 23, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media
• Pneumococcal Infections
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Colombia	GSK Investigational Site	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata.	Up to 7 years : from January 2008 to December 2014
Secondary	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	morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata	Up to 7 years : from January 2008 to December 2014
Secondary	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
Secondary	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	* 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.	Up to 7 years : from January 2008 to December 2014
Secondary	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

External Links

•   Results for study 203127 can be found on the GSK Clinical Study Register