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Trial record 13 of 277 for:    Panama

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
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date August 26, 2016
First Posted Date August 31, 2016
Last Update Posted Date September 27, 2018
Actual Study Start Date September 11, 2017
Actual Primary Completion Date September 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2017)
Occurrence of seasonal influenza A and/or B cases by age, virus subtype and strain lineage, in Panama, selected countries of Central America and the Caribbean (using the data reported via National Influenza Surveillance Program). [ Time Frame: From January 2010 to December 2015 ]
Assessment by age ranges- <1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥65 years, virus subtype- A-virus subtype (AH1N1/A H3N2) and B-strain lineage (Victoria and Yamagata).
Original Primary Outcome Measures
 (submitted: August 26, 2016)
Occurrence of seasonal influenza A and/or B cases by age, virus subtype and strain lineage, in Panama, selected countries of Central America and the Caribbean (using the data reported via National Influenza Surveillance Program). [ Time Frame: From January 2010 to December 2015 ]
Change History Complete list of historical versions of study NCT02885246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 27, 2017)
  • Occurrence of clinical features and outcomes (clinical symptoms, duration of illness, complications) experienced by subjects who have laboratory confirmed diagnosis seasonal influenza A and/or B. [ Time Frame: From January 2010 to December 2015 ]
    Clinical features and outcomes experienced by influenza positive subjects by type of influenza (seasonal influenza A and/or B) in different seasons from 2010-2015.
  • Evaluation of frequency of seasonal influenza A and/or B cases reported in different temporal and geographical locations. [ Time Frame: From January 2010 to December 2015 ]
    Assessment by geographical distribution by country and by region within the country (if data available).
  • Occurrence of influenza caused by B-strain and presented by B lineages among the study population by age and by region. [ Time Frame: From January 2010 to December 2015 ]
    Assessment by age ranges- <1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥65 and by selected study regions.
  • Comparison of characteristics of the influenza B-infection as observed in the database and the B-strain included in the trivalent influenza vaccine. [ Time Frame: From January 2010 to December 2015 ]
    Estimation of the proportion of matched B-strains and mis-matched B-strains.
Original Secondary Outcome Measures
 (submitted: August 26, 2016)
  • Occurrence of clinical features and outcomes (clinical symptoms, duration of illness, complications) experienced by subjects who have laboratory confirmed diagnosis seasonal influenza A and/or B. [ Time Frame: From January 2010 to December 2015 ]
  • Evaluation of frequency of seasonal influenza A and/or B cases reported in different temporal and geographical locations. [ Time Frame: From January 2010 to December 2015 ]
  • Occurrence of influenza caused by B-strain and presented by B lineages among the study population, by age (<1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥ 65 years) and by region. [ Time Frame: From January 2010 to December 2015 ]
  • Comparison of characteristics of the influenza B-infection as observed in the database and the B-strain included in the trivalent influenza vaccine. [ Time Frame: From January 2010 to December 2015 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Influenza Group
All subjects who have laboratory confirmed diagnosis of influenza (laboratory confirmed case) and reported in the national influenza surveillance system from the Year 2010-2015.
Intervention: Other: Data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 26, 2016)
1
Original Estimated Enrollment Same as current
Actual Study Completion Date September 17, 2018
Actual Primary Completion Date September 17, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Panama
Removed Location Countries  
 
Administrative Information
NCT Number NCT02885246
Other Study ID Numbers 205049
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2018