Influenza, HumanNCT02885246
Prevalence, Strain Circulation and Disease Burden Study of Seasonal Influenza A and B in Panama, Selected Countries of Central America and the Caribbean From the Year 2010 to 2015
An observational study of Influenza, Human, run by GlaxoSmithKline at 1 site in Panama.
Trial summary
The purpose of this study is to assess the prevalence, strain circulation and disease burden of seasonal Influenza A and B in Panama, selected countries of Central America and the Caribbean from the Year 2010 to 2015. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Data collection
- How many people
- 1,839 participants
- Where
- 1 sitePanama
- Study dates
- 11 Sep 2017to 17 Sep 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Total population will include all subjects included in the study. Information will only be collected for all eligible subjects (aggregated) captured by the ICGES Database.
Who may be able to join
- All subjects diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2010 to December 2015.
Who cannot join
- N/A.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence, Strain Circulation and Disease Burden of Seasonal Influenza A and B in Panama, Selected Countries of Central America and the Caribbean From the Year 2010 to 2015
The purpose of this study is to assess the prevalence, strain circulation and disease burden of seasonal Influenza A and B in Panama, selected countries of Central America and the Caribbean from the Year 2010 to 2015.
Read the detailed description
The Gorgas Memorial Institute for Health Studies (ICGES) is a public health institution established in Panama dedicated to health research and disease prevention. It has been performing virological isolations of influenza and is a part of the World Health Organisation (WHO) Global Influenza Surveillance and Response System (GISRS) and a direct collaborator of the Centre for Disease Control and Prevention (CDC).
From 2010 a sentinel surveillance program is being conducted in Panama within the ICGES to collect data on influenza and other respiratory viruses using CDC guidance for Respiratory Disease Surveillance. This study aims to utilize this data source for analyzing the burden of influenza within the region.
- Conditions
- Influenza, Human
- Being tested
- Data collection
- Keywords
- Panama, Influenza B, Influenza A, Strain circulation, Database
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
The ICGES database of Panama will be checked for all seasonal influenza A and/or B positive cases reported via influenza surveillance programs from 2010 to 2015.
| Study group | Role | What they receive |
|---|---|---|
| Influenza Virus Positive Group | The group included specimen samples with a laboratory confirmed diagnosis of influenza A and/or B, reported in the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seasonal Influenza A and /or B Cases by Age Group, in Panama (Using the Data Reported Via National Influenza Surveillance Program)
The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years and Unspecified age, instead of <1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥ 65 years, as initially described in the Protocol. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Number of Seasonal Influenza A Cases by Virus Subtypes, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B
The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by virus subtype (H1N1 and H3N2) and the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Number of Seasonal Influenza B Cases by Strain Lineage, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B
The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by lineage (Victoria and Yamagata) and the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Secondary outcomes (6)
Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Clinical Features (Clinical Symptoms)
The signs and symptoms assessed were: Fever, Cough, Sore throat, Rhinorrhea, Dyspnea, Vomiting, Diarrhea, Myalgias, Nausea, Headache, Wheezing, Apnea, Tachypnea, Polypnea, Arthralgia, Chest Pain, Convulsion, Hyporexia, Weakness, Irritability, Odynophagia, Abdominal pain, Conjunctivitis, Cyanosis and Chills. Each sign and symptom was assessed in four categories: yes = presence of sign/symptom; no = absence of sign/symptom; form not filled = no epi surveillance form available; and unspecified= no data on the Epi surveillance form. Analysis related to duration of the illness was not performed as the data was not collected. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Outcomes (Complications)
The outcomes were categorized as follows: Outpatient, Hospitalised, Dead or Unspecified (i.e. missing data on the epidemiology surveillance form). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Number of Seasonal Influenza A and /or B Cases by Southern Hemisphere, Within Different Seasons From 2011 to 2017
The cases were stratified by influenza type and Southern hemisphere Influenza seasonal period (May-October of each year 2011-2017). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
Number of Seasonal Influenza A and /or B Cases by Region, Within Study Period From 2011 to 2017
The cases were stratified by region. Regions were classified as follows: West, Central, Panama, Northeast, Unspecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Number of Influenza Cases Caused by B- Strain and Presented by B-lineage and by Region Among All Influenza Cases A and/or B
The cases were stratified by lineage (Victoria and Yamagata) and region. Regions were classified as follows: West, Central, Panama, Northeast, Unspecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: From January 2011 to December 2017
Number of Circulating Influenza B Lineage Positive Specimens Mismatch With the B-strain Vaccine Recommendation, Among the Number of Influenza B Positive Specimens, by Influenza Seasons
Comparison of characteristics of the influenza B-infection Victoria (V) or Yamagata (Y) as observed in the database and the B-strain included in the trivalent influenza vaccine expressed as the number of cases with B-lineage-level mismatch between trivalent seasonal influenza vaccines and circulating viruses observed during the study period. Categories are defined as follows: e.g. for the first category:"V.(B/Brisbane/60/2008)vsVictoria-May-Oct 2011" corresponds to Southern hemisphere influenza season of "May-Oct 2011" with vaccine recommendation: "Victoria (B/Brisbane/60/2008-like virus)" compared to circulating Influenza B lineages "Victoria". Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Measured: Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start11 Sep 2017
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza, HumanStudies 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
- 1,839 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
- NCT02885246
- Sponsor's protocol ID
- 205049
- Status last verified
- Mar 2020
- First submitted
- 26 Aug 2016
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Strain Circulation and Disease Burden of Seasonal Influenza A and B in Panama, Selected Countries of Central America and the Caribbean From the Year 2010 to 2015
- ClinicalTrials.gov ID
- NCT02885246
- Acronym / sponsor ID
- 205049
- Conditions
- Influenza, Human
- Keywords
- Panama, Influenza B, Influenza A, Strain circulation, Database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,839 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 3 Mar 2020
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 assess the prevalence, strain circulation and disease burden of seasonal Influenza A and B in Panama, selected countries of Central America and the Caribbean from the Year 2010 to 2015.
Detailed description
The Gorgas Memorial Institute for Health Studies (ICGES) is a public health institution established in Panama dedicated to health research and disease prevention. It has been performing virological isolations of influenza and is a part of the World Health Organisation (WHO) Global Influenza Surveillance and Response System (GISRS) and a direct collaborator of the Centre for Disease Control and Prevention (CDC).
From 2010 a sentinel surveillance program is being conducted in Panama within the ICGES to collect data on influenza and other respiratory viruses using CDC guidance for Respiratory Disease Surveillance. This study aims to utilize this data source for analyzing the burden of influenza within the region.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza Virus Positive Group | – | Other: Data collectionThe group included specimen samples with a laboratory confirmed diagnosis of influenza A and/or B, reported in the Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES) database of Panama, from January 2011 to December 2017. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Total population will include all subjects included in the study. Information will only be collected for all eligible subjects (aggregated) captured by the ICGES Database.
Key inclusion criteria (1 listed)
- All subjects diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2010 to December 2015.
Key exclusion criteria (1 listed)
- N/A.
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 collectionThe ICGES database of Panama will be checked for all seasonal influenza A and/or B positive cases reported via influenza surveillance programs from 2010 to 2015. | Other | Influenza Virus Positive Group |
Primary outcome
Number of Seasonal Influenza A and /or B Cases by Age Group, in Panama (Using the Data Reported Via National Influenza Surveillance Program)
Time frame: From January 2011 to December 2017
The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years and Unspecified age, instead of <1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥ 65 years, as initially described in the Protocol. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Number of Seasonal Influenza A Cases by Virus Subtypes, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B
Time frame: From January 2011 to December 2017
The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by virus subtype (H1N1 and H3N2) and the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
Number of Seasonal Influenza B Cases by Strain Lineage, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B
Time frame: From January 2011 to December 2017
The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by lineage (Victoria and Yamagata) and the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.
6 secondary outcomes
Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Clinical Features (Clinical Symptoms)
Time frame: From January 2011 to December 2017
Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Outcomes (Complications)
Time frame: From January 2011 to December 2017
Number of Seasonal Influenza A and /or B Cases by Southern Hemisphere, Within Different Seasons From 2011 to 2017
Time frame: Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
Number of Seasonal Influenza A and /or B Cases by Region, Within Study Period From 2011 to 2017
Time frame: From January 2011 to December 2017
Number of Influenza Cases Caused by B- Strain and Presented by B-lineage and by Region Among All Influenza Cases A and/or B
Time frame: From January 2011 to December 2017
Number of Circulating Influenza B Lineage Positive Specimens Mismatch With the B-strain Vaccine Recommendation, Among the Number of Influenza B Positive Specimens, by Influenza Seasons
Time frame: Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Influenza, Human, run by GlaxoSmithKline at 1 site in Panama.
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 6 Apr 2020. 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 Panama. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Seasonal Influenza A and /or B Cases by Age Group, in Panama (Using the Data Reported Via National Influenza Surveillance Program) (time frame: From January 2011 to December 2017). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2020.