Last updated: 06/07/2019 12:10:46

Vaccination impact against pneumococcal disease on Acute Otitis Media morbidity in Colombian children < 5 years of age

GSK study ID
203127
See study documents
Clinicaltrials.gov ID
NCT02567747
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Impact of vaccination against pneumococcal disease on the morbidity of Acute Otitis Media in Colombian children < 5 years of age
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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:

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

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

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

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

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

Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Other
Primary completion date:
2018-01-02
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Acute otitis media, Pneumonia
Product
GSK2647154A
Collaborators
Not applicable
Study date(s)
October 2015 to February 2018
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
0 minutes - 59 months
Accepts healthy volunteers
Yes
  • 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.
  • Not applicable
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bogota, Colombia
Status
Study Complete
Contact us

Study documents

Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2018-01-02
Actual study completion date
2018-23-02

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Participate in clinical trial
Additional information
Results for study 203127 can be found on the GSK Clinical Study Register
Click here
Access to clinical trial data by researchers
Visit website