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
Study complete
Study complete
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
    Primary completion date:
    2018-01-02
    Observational study model:
    Other
    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
    Study complete
    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