Clinical trial NCT02567747: Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
Official title: Impact of Vaccination Against Pneumococcal Disease on the Morbidity of Acute Otitis Media in Colombian Children < 5 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Otitis Media
Pneumonia
Keywords: Colombia
otitis
Database
pneumonia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 1
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible subjects (aggregated) captured by the selected national databases in Columbia.

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 7 years : from January 2008 to December 2014
Secondary outcomes:
measure: 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
timeFrame: Up to 7 years : from January 2008 to December 2014
measure: 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
timeFrame: Up to 7 years : from January 2008 to December 2014
measure: 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
timeFrame: Up to 7 years : from January 2008 to December 2014
measure: 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
timeFrame: Up to 7 years : from January 2008 to December 2014
measure: 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.
timeFrame: Up to 7 years : from January 2008 to December 2014
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.