Last updated: 10/01/2021 12:40:05
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of seasonal Influenza A and /or B cases by age group, in Panama (using the data reported via National Influenza Surveillance Program)
Timeframe: 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
Timeframe: 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
Timeframe: From January 2011 to December 2017
Secondary outcomes:
Number of cases with laboratory confirmed diagnosis seasonal influenza A and/or B who experienced clinical features (clinical symptoms)
Timeframe: From January 2011 to December 2017
Number of cases with laboratory confirmed diagnosis seasonal influenza A and/or B who experienced outcomes (complications)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: From January 2011 to December 2017
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
Timeframe: Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)
Interventions:
Other: Data collection
Enrollment:
1839
Observational study model:
Other
Primary completion date:
2018-17-09
Time perspective:
Retrospective
Clinical publications:
Pascale JM, Franco D, Devadiga R, De Antonio R, Dominguez-Salazar EL, dos Santos G, Juliao P. Burden of seasonal influenza A and B in Panama from 2011 to 2017: An observational retrospective database study. Infect Dis Ther. 2021;
DOI: http://dx.doi.org/ 10.1007/s40121-021-00501-y
Medical condition
Influenza, Human
Product
GSK2321138A
Collaborators
Not applicable
Study date(s)
September 2017 to September 2018
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- All subjects diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2010 to December 2015.
- N/A.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2018-17-09
Actual study completion date
2018-17-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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