- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885246
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
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
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Panama, Panama
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All subjects diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2010 to December 2015.
Exclusion Criteria:
- N/A.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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From January 2011 to December 2017
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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
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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.
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From January 2011 to December 2017
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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
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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.
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From January 2011 to December 2017
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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From January 2011 to December 2017
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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
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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.
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From January 2011 to December 2017
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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)
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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.
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Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
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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
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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.
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From January 2011 to December 2017
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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
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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.
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From January 2011 to December 2017
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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)
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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.
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Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205049
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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