- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02742753
Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
June 6, 2019 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, 103 59
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children living in the county councils of VGR and Skåne during the study period.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Study cohort
The Total population will include all subjects included in the study.
Only aggregated information will be collected for these subjects.
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Data will be collected retrospectively linking regional patient-level data prospectively captured in real-world clinical setting with mandatory national healthcare registries from 2004 to 2013.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: During 10 years: from January 1, 2004 to December 31, 2013
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A step-wise approach will be applied: 1. Descriptive analyses to assess any trends in OM and AOM incidence, any seasonality (repeating pattern of incidence related to time such as seasons, quarters and months), the order of seasonality, extreme observations/outliers, whether incidence trends include abrupt changes.
2. If trends or seasonality are identified, a time series analysis will be conducted in 2 steps.
a.
Time series analysis of monthly incidence, using smoothing technique to estimate differences in pre-PCV, PCV7, and Synflorix®/PCV13 vaccination periods.
b.
Interrupted time-series analysis if the above steps show any differences in pre- and post- vaccination introduction periods.
Diagnoses of AOM recorded under the ICD-10 code H66 (suppurative and unspecified OM) and ICD-10 H66.0 (acute suppurative OM); Chronic OM under ICD-10 code H66.3 (other chronic suppurative OM) and other OM underICD-10 code H66.9 (OM unspecified) and H65 (non-suppurative OM).
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During 10 years: from January 1, 2004 to December 31, 2013
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: During 10 years: from January 1, 2004 to December 31, 2013
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The impact of PCV will be investigated by looking at trends over time in the rate of antibiotics* dispensed due to an OM or AOM diagnosis for the two counties separately.
The analysis of rate of antibiotic use will be performed in two steps as: Descriptive statistics for the number of dispensed antibiotics.
Time series analysis for the incidence of dispensed antibiotics.
*Date of an antibiotic dispensed within 7 days of a registered diagnosis code (ICD-10 code H65, H66, H66.0, H66.3, H66.9).
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During 10 years: from January 1, 2004 to December 31, 2013
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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
Time Frame: During 10 years: from January 1, 2004 to December 31, 2013
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The rate of tympanostomy tube insertions* among children with OM or AOM will also be analyzed in the same way as the analysis of frequency of antibiotics dispensed.
*Date of Tympanostomy tube placement procedure (KVA DCD10).
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During 10 years: from January 1, 2004 to December 31, 2013
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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
Time Frame: During 10 years: from January 1, 2004 to December 31, 2013
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The impact of PCVs on the incidence of severe AOM among children will be analysed with a step-wise time series analysis approach, which is described for the primary outcome.
Severe AOM defined as: -Children diagnosed with AOM with presence of moderate to severe otalgia or fever ≥ 39° C, or -Children with ≥3 diagnoses of AOM in a 6-month period or ≥4 AOM diagnoses in a 12-month period, or-Children reported with hospitalization due to AOM or any documented evidence of IV infusion of antibiotics in hospital.
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During 10 years: from January 1, 2004 to December 31, 2013
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Assessment of the Costs for OM and AOM-related healthcare resource utilization
Time Frame: During 10 years: from January 1, 2004 to December 31, 2013
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Cost dispersion statistics (mean, median, standard deviation, minimum, maximum, variance) will be calculated.
Direct costs for OM and AOM will be calculated by including healthcare resource utilization for each child as the count of antibiotic prescriptions filled for OM and AOM, and use of medical services, such as visits to the general practitioner, visits to the hospital, procedure costs (tympanostomy tube placements, myringotomies and IV antibiotics administrations) and length of hospital stay during the follow-up period.
Cost for all health care visits and procedures will be calculated using the number of registered events multiplied by a unit cost based on public price lists for that particular visit or procedure.
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During 10 years: from January 1, 2004 to December 31, 2013
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Assessment of possible individual-level predictors for the time to the first OM or AOM diagnosis
Time Frame: During 10 years: from January 1, 2004 to December 31, 2013
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The following analysis will be conducted to understand individual-level factors that impacts OM and AOM rates and time to first incidence of an OM or an AOM separately for each county council.
A survival analysis will be conducted to assess predictors of the time to first OM or AOM using a left censored Cox proportional hazards model.
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During 10 years: from January 1, 2004 to December 31, 2013
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2016
Primary Completion (Actual)
May 18, 2017
Study Completion (Actual)
September 14, 2017
Study Registration Dates
First Submitted
April 11, 2016
First Submitted That Met QC Criteria
April 14, 2016
First Posted (Estimate)
April 19, 2016
Study Record Updates
Last Update Posted (Actual)
June 10, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 203129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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