Last updated: 08/16/2021 05:00:10
Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2017-18-05
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)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
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
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
Click hereAccess to clinical trial data by researchers
Visit website