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

NCT02742753 | Completed

• 1 other identifier: 203129
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Otitis Media; Otitis Media

Keywords

Otitis; Vaccine; Sweden; Database

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

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

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

  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

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

Study Arms (1)

Study cohort

The Total population will include all subjects included in the study. Only aggregated information will be collected for these subjects.

Other: Data collection

Interventions

Data collection OTHER

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 cohort

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children living in the county councils of VGR and Skåne during the study period.

You may qualify if:

• Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Stockholm, 103 59, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32574101 DERIVED

Related Links

• Results for study 203129 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Otitis Media; Otitis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 19, 2016
• Study Start: June 16, 2016
• Primary Completion: May 18, 2017
• Study Completion: September 14, 2017
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)