Acute Otitis MediaNCT02567747
Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
An observational study of Acute Otitis Media and Pneumonia, run by GlaxoSmithKline at 1 site in Colombia.
Trial summary
The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the introduction of vaccination against pneumococcal disease within the Universal Mass Vaccination… Read more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media, Pneumonia
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2015to 23 Feb 2018
- 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 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All eligible subjects (aggregated) captured by the selected national databases in Columbia.
Who may be able to join
- Children aged less than five years with record of acute otitis media (with ICD-10 codes: H65 to H66) AND/OR.
- Children aged less than five years with record of pneumonia (with ICD-10 codes: J13 to J18) AND/OR.
- Children aged less than five years with any ICD-10 codes for respiratory diseases (J00-J99).
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vaccination Against Pneumococcal Disease on the Morbidity of Acute Otitis Media in Colombian Children < 5 Years of Age
The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the introduction of vaccination against pneumococcal disease within the Universal Mass Vaccination (UMV) in Colombia.
- Conditions
- Acute Otitis Media, Pneumonia
- Being tested
- Data collection
- Keywords
- Colombia, otitis, Database, pneumonia
- Medical subject headings
- Otitis Media, Pneumonia, 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 for cases identified through RIPS*/ DANE from 2008 until 2014 and through PAI* from 2009 until 2014. *Registro Individual de Prestación de Servicios de Salud (RIPS) database (Health Service Provider Individual Registration Database), Columbia. Departamento Administrativo Nacional de Estadística (DANE) database (The National Administrative Department of Statistics database), Columbia. *Programa Ampliado de Immunizaciones (PAI) database (National Immunization Program database), Columbia.
| 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.
Occurrence of reported cases of AOM in children below 5 years of age, in post-vaccination period compared to pre-vaccination period of PCV vaccination in UMV
Measured: Up to 7 years : from January 2008 to December 2014
Secondary outcomes (5)
Occurrence of reported cases of AOM in children by morbidity, age group, and department in children in post-vaccination period compared to pre-vaccination period of PCV vaccination
Morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata.
Measured: Up to 7 years : from January 2008 to December 2014
Occurrence of reported cases of pneumonia and acute respiratory infections, overall and by morbidity, age groups, and department in children below 5 years of age before and after implementation of PCV vaccination into the UMV
morbidity including hospitalization, outpatient visits and ICD-10 code type, age groups including 0-24 months and 25-59 months strata
Measured: Up to 7 years : from January 2008 to December 2014
Occurrence of reported deaths due to pneumonia and acute respiratory infections by age group (0-24 months and 25-59 months), department and overall in children below 5 years of age before and after implementation of PCV vaccination into the UMV
Measured: Up to 7 years : from January 2008 to December 2014
Occurrence of AOM related health care resources used and costs* before and after implementation of PCV vaccination into UMV by age group (0-24 months and 25-59 months) and overall
- Cost calculation (e.g. medical procedures , physician visits [outpatient/inpatient and length of stay]) will be extracted from Medical Procedure Cost Manual from the MOH for this analysis: http://www.fasecolda.com/index.php/ramos/soat/tarifas-y-coberturas/manual-tarifario-de-salud/. Tympanostomies/myringotomies, myringotomies with insertion of ventilation tubes, etc.
Measured: Up to 7 years : from January 2008 to December 2014
Total number of doses (complete or partial) of PCV vaccination administered in infants <1year of age after its introduction into the UMV program in Colombia.
Measured: Up to 7 years : from January 2008 to December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Feb 2018
- Study completion23 Feb 2018
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
- NCT02567747
- Sponsor's protocol ID
- 203127
- Status last verified
- Jun 2019
- First submitted
- 28 Sep 2015
- Last updated
- 10 Jun 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Carrasquilla G, Porras-Ramirez A, Martinez S, DeAntonio R, Devadiga R, Talarico C, Caceres DC, Castrejon MM, Juliao P. Trends in all-cause pneumonia and otitis media in children aged <2 years following pneumococcal conjugate vaccine introduction in Colombia. Hum Vaccin Immunother. 2021 Apr 3;17(4):1173-1180. doi: 10.1080/21645515.2020.1805990. Epub 2020 Sep 23.
PubMed 32966144
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 Vaccination Against Pneumococcal Disease on the Morbidity of Acute Otitis Media in Colombian Children < 5 Years of Age
- ClinicalTrials.gov ID
- NCT02567747
- Acronym / sponsor ID
- 203127
- Conditions
- Acute Otitis Media, Pneumonia
- Keywords
- Colombia, otitis, Database, pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 5 Oct 2015 (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 purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the introduction of vaccination against pneumococcal disease within the Universal Mass Vaccination (UMV) in Colombia.
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 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All eligible subjects (aggregated) captured by the selected national databases in Columbia.
Key inclusion criteria (3 listed)
- Children aged less than five years with record of acute otitis media (with ICD-10 codes: H65 to H66) AND/OR.
- Children aged less than five years with record of pneumonia (with ICD-10 codes: J13 to J18) AND/OR.
- Children aged less than five years with any ICD-10 codes for respiratory diseases (J00-J99).
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 for cases identified through RIPS*/ DANE from 2008 until 2014 and through PAI* from 2009 until 2014. *Registro Individual de Prestación de Servicios de Salud (RIPS) database (Health Service Provider Individual Registration Database), Columbia. Departamento Administrativo Nacional de Estadística (DANE) database (The National Administrative Department of Statistics database), Columbia. *Programa Ampliado de Immunizaciones (PAI) database (National Immunization Program database), Columbia. | Other | Study cohort |
Primary outcome
Occurrence of reported cases of AOM in children below 5 years of age, in post-vaccination period compared to pre-vaccination period of PCV vaccination in UMV
Time frame: Up to 7 years : from January 2008 to December 2014
5 secondary outcomes
Occurrence of reported cases of AOM in children by morbidity, age group, and department in children in post-vaccination period compared to pre-vaccination period of PCV vaccination
Time frame: Up to 7 years : from January 2008 to December 2014
Occurrence of reported cases of pneumonia and acute respiratory infections, overall and by morbidity, age groups, and department in children below 5 years of age before and after implementation of PCV vaccination into the UMV
Time frame: Up to 7 years : from January 2008 to December 2014
Occurrence of reported deaths due to pneumonia and acute respiratory infections by age group (0-24 months and 25-59 months), department and overall in children below 5 years of age before and after implementation of PCV vaccination into the UMV
Time frame: Up to 7 years : from January 2008 to December 2014
Occurrence of AOM related health care resources used and costs* before and after implementation of PCV vaccination into UMV by age group (0-24 months and 25-59 months) and overall
Time frame: Up to 7 years : from January 2008 to December 2014
Total number of doses (complete or partial) of PCV vaccination administered in infants <1year of age after its introduction into the UMV program in Colombia.
Time frame: Up to 7 years : from January 2008 to December 2014
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 32966144Carrasquilla G, Porras-Ramirez A, Martinez S, DeAntonio R, Devadiga R, Talarico C, Caceres DC, Castrejon MM, Juliao P. Trends in all-cause pneumonia and otitis media in children aged <2 years following pneumococcal conjugate vaccine introduction in Colombia. Hum Vaccin Immunother. 2021 Apr 3;17(4):1173-1180. doi: 10.1080/21645515.2020.1805990. Epub 2020 Sep 23.
- Results for study 203127 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
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 Pneumonia, run by GlaxoSmithKline at 1 site in Colombia.
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 3 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 Colombia. 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?
Occurrence of reported cases of AOM in children below 5 years of age, in post-vaccination period compared to pre-vaccination period of PCV vaccination in UMV (time frame: Up to 7 years : from January 2008 to December 2014). 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 NCT02567747, 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.