Last updated: 08/16/2021 05:00:10

Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children

GSK study ID
203129
See study documents
Clinicaltrials.gov ID
NCT02742753
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 Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
Trial description: The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish children by collecting and analyzing patient level observational data already available in existing regional and national databases.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assessment of the impact of PCVs by describing, separately for Skåne and VGR (Västra Götalandsregionen), trends over time in the incidence of OM and AOM among children during the pre-PCV, PCV7, and Synflorix®/PCV13-eras

Timeframe: During 10 years: from January 1, 2004 to December 31, 2013

Secondary outcomes:

Assessment of the impact of PCVs by describing trends over time in the rate of antibiotics dispensed for OM and AOM diagnoses among children with OM or AOM

Timeframe: During 10 years: from January 1, 2004 to December 31, 2013

Assessment of the the impact of PCVs by describing trends over time in the rate of tympanostomy tube insertions among children with OM and AOM

Timeframe: During 10 years: from January 1, 2004 to December 31, 2013

Assessment of the impact of PCVs by describing the trends over time in the incidence of severe AOM (Medical Products Agency 2010, Lieberthal 2013) among children

Timeframe: During 10 years: from January 1, 2004 to December 31, 2013

Assessment of the Costs for OM and AOM-related healthcare resource utilization

Timeframe: During 10 years: from January 1, 2004 to December 31, 2013

Assessment of possible individual-level predictors for the time to the first OM or AOM diagnosis

Timeframe: During 10 years: from January 1, 2004 to December 31, 2013

Interventions:
  • Other: Data collection
    • Enrollment:
    1
    Primary completion date:
    2017-18-05
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Mark Edmondson-Jones, Therese Dibbern, Marcus Hultberg, Bengt Anell, Emma Medin, Yang Feng, Carla Talarico. Impact of pneumococcal conjugate vaccines on healthcare utilization and direct costs for otitis media in children ≤2 years of age in two Swedish regions. Hum Vaccin Immunother. 2021;Online ahead of print. doi: 10.1080/21645515.2021.1942712.
    Medical condition
    Acute otitis media, Streptococcus pneumoniae
    Product
    GSK2647154A
    Collaborators
    Not applicable
    Study date(s)
    June 2016 to September 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    0 minutes - 5 years
    Accepts healthy volunteers
    Yes
    • Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)
    • Not Applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004
    • 2013)
    Exclusion criteria:
    • Not Applicable

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Stockholm, Sweden, 103 59
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2017-18-05
    Actual study completion date
    2017-14-09

    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 203129 can be found on the GSK Clinical Study Register
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