Acute Otitis MediaNCT02742753
Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
An observational study of Acute Otitis Media and Otitis Media, run by GlaxoSmithKline at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media, Otitis Media
- What is being tested?
- Data collection
- How many people
- 1 participants
- Where
- 1 siteSweden
- Study dates
- 16 Jun 2016to 14 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children living in the county councils of VGR and Skåne during the study period.
Who may be able to join
- Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Otitis Media, Otitis Media
- Being tested
- Data collection
- Keywords
- Otitis, Vaccine, Sweden, Database
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | The Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: During 10 years: from January 1, 2004 to December 31, 2013
Secondary outcomes (5)
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
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).
Measured: 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
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).
Measured: 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
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.
Measured: During 10 years: from January 1, 2004 to December 31, 2013
Assessment of the Costs for OM and AOM-related healthcare resource utilization
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.
Measured: 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
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.
Measured: During 10 years: from January 1, 2004 to December 31, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start16 Jun 2016
- Primary completion18 May 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742753
- Sponsor's protocol ID
- 203129
- Status last verified
- Jun 2019
- First submitted
- 11 Apr 2016
- Last updated
- 10 Jun 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Edmondson-Jones M, Dibbern T, Hultberg M, Anell B, Medin E, Feng Y, Talarico C. The effect of pneumococcal conjugate vaccines on otitis media from 2005 to 2013 in children aged </=5 years: a retrospective cohort study in two Swedish regions. Hum Vaccin Immunother. 2021 Feb 1;17(2):517-526. doi: 10.1080/21645515.2020.1775455. Epub 2020 Jun 23.
PubMed 32574101
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
- ClinicalTrials.gov ID
- NCT02742753
- Acronym / sponsor ID
- 203129
- Conditions
- Acute Otitis Media, Otitis Media
- Keywords
- Otitis, Vaccine, Sweden, Database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: Data collectionThe Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children living in the county councils of VGR and Skåne during the study period.
Key inclusion criteria (1 listed)
- Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData 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. | Other | Study cohort |
Primary outcome
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
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).
5 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
Time frame: 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
Time frame: 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
Time frame: During 10 years: from January 1, 2004 to December 31, 2013
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 32574101Edmondson-Jones M, Dibbern T, Hultberg M, Anell B, Medin E, Feng Y, Talarico C. The effect of pneumococcal conjugate vaccines on otitis media from 2005 to 2013 in children aged </=5 years: a retrospective cohort study in two Swedish regions. Hum Vaccin Immunother. 2021 Feb 1;17(2):517-526. doi: 10.1080/21645515.2020.1775455. Epub 2020 Jun 23.
- Results for study 203129 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Otitis Media and Otitis Media, run by GlaxoSmithKline at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.