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

NCT02567747 | Completed

• 1 other identifier: 203127
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Otitis Media; Pneumonia

Keywords

Colombia; otitis; Database; pneumonia

Outcome Measures

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

  Up to 7 years : from January 2008 to December 2014

Secondary Outcomes (5)

• 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

• 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

• 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 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

• 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

Study Arms (1)

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

Interventions

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.

Study cohort

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All eligible subjects (aggregated) captured by the selected national databases in Columbia.

You may qualify if:

• 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).

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bogotá, Colombia

Location

Related Publications (1)

• 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.

  PMID: 32966144 DERIVED

Related Links

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

MeSH Terms

Conditions

Otitis Media; Pneumonia; Otitis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 23, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)