Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil
| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2010 | ||||
| Last Updated Date | November 21, 2012 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01171157 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil | ||||
| Official Title ICMJE | An Observational Case Control Study of Effectiveness of Influenza Vaccination and Burden of Illness in Community-dwelling Elderly With Influenza-like Illness in Southern Brazil | ||||
| Brief Summary | The purpose of this research study is to estimate how many elderly people who have symptoms that look like influenza (i.e. an influenza-like illness) actually have the disease and how effective influenza vaccines are in preventing influenza in elderly people. The study will also examine the severity of the disease (e.g. how long are people ill, were there any complications) and how it affects everyday life (e.g. cost, medications, care by family members). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: One nose/throat swab |
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| Sampling Method | Probability Sample | ||||
| Study Population | Adults aged 65 years and over, consulting a physician for an influenza-like illness during the influenza season. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Routine sample collection
Collection of routine nasal/throat swab samples |
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| Study Group/Cohort (s) | Group 1
Subjects with influenza like illness
Intervention: Other: Routine sample collection |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01171157 | ||||
| Other Study ID Numbers ICMJE | 112868 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | GlaxoSmithKline | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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