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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

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ClinicalTrials.gov Identifier: NCT02885246
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment
Influenza, Human Other: Data collection

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 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.

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Study Type : Observational
Actual Enrollment : 1839 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
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.
Other: Data collection
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.




Primary Outcome Measures :
  1. 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 Uspecified 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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 ]
    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, Conjuntivitis, 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 surveilance 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.

  2. 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 ]
    The outcomes were categorized as follows: Outpatient, Hospitalised, Dead or Unspecified (i.e. missing data on the EPI surveillance form). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

  3. 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) ]
    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.

  4. 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 ]
    The cases were stratified by region. Regions were classified as follows: West, Central, Panama, Northeast, Unpecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

  5. 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 ]
    The cases were stratified by lineage (Victoria and Yamagata) and region. Regions were classified as follows: West, Central, Panama, Northeast, Unpecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.

  6. 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885246


Locations
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Panama
GSK Investigational Site
Panama, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] March 29, 2016
Statistical Analysis Plan  [PDF] September 20, 2017


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02885246    
Other Study ID Numbers: 205049
First Posted: August 31, 2016    Key Record Dates
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020
Keywords provided by GlaxoSmithKline:
Panama
Influenza B
Influenza A
Strain circulation
Database
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases