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

NCT02885246 | Completed Results

• 1 other identifier: 205049
• Study Type: observational
• Target: 1,839
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

Panama; Influenza B; Influenza A; Strain circulation; Database

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Clinical Features (Clinical Symptoms)

  From January 2011 to December 2017

• Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Outcomes (Complications)

  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

  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

  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

  From January 2011 to December 2017

Study Arms (1)

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

Interventions

Data collection OTHER

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.

Influenza Virus Positive Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All subjects diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2010 to December 2015.

You may not qualify if:

• N/A.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Panama City, Panama

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

gskclinicalhd@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: September 11, 2017
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: April 6, 2020
• Results First Posted: March 3, 2020

Record last verified: 2020-03

Locations

PA (1)