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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885246
• Other study ID #: 205049
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: September 17, 2018

Study information

• Verified date: March 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1839
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
Panama	GSK Investigational Site	Panama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From January 2011 to December 2017
Primary	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.	From January 2011 to December 2017
Primary	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.	From January 2011 to December 2017
Secondary	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.	From January 2011 to December 2017
Secondary	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.	From January 2011 to December 2017
Secondary	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.	Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
Secondary	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.	From January 2011 to December 2017
Secondary	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.	From January 2011 to December 2017
Secondary	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.	Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)