Last updated: 11/03/2018 13:46:55

Effectiveness of flu vaccination and burden of illness among community-dwelling elderly with influenza like illness in Brazil

GSK study ID
112868
See study documents
Clinicaltrials.gov ID
NCT01171157
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B

Timeframe: At enrolment (day 0)

Secondary outcomes:

Number of days of illness since onset of influenza-like illness

Timeframe: At the follow-up contact (between day 12 and 28)

Number of days of reduced activity since onset of influenza-like illness

Timeframe: At the follow-up contact (between day 12 and 28)

Number of days off work of other family members or caregivers to provide patient care since onset of influenza-like illness

Timeframe: At the follow-up contact (between day 12 and 28)

Number of medical visits related to influenza-like illness since Visit 1

Timeframe: At the follow-up contact (between day 12 and 28)

Use of medication since onset of influenza-like illness

Timeframe: At the follow-up contact (between day 12 and 28)

Occurrence of complications since onset of influenza-like illness

Timeframe: At the follow-up contact (between day 12 and 28)

Hospitalization since onset of influenza-like illness

Timeframe: At the follow-up contact (between day 12 and 28)

Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR

Timeframe: At enrolment (day 0)

Number of deaths

Timeframe: At the follow-up contact (between day 12 and 28)

Clinical features related to influenza-like illness

Timeframe: At enrolment (day 0)

Interventions:
  • Other: Routine sample collection
    • Enrollment:
    4
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Control
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK2186877A, GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    May 2009 to June 2009
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    65+ years
    Accepts healthy volunteers
    No
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
    • A male or female >= 65 years of age.
    • Receipt of any experimental influenza vaccine within 6 months of the onset of the influenza-like illness.
    • Terminal stage of disease.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

      • A male or female >= 65 years of age.
      • Written informed consent obtained from the subject.
      • Presenting within the first 72 hours of an influenza-like illness. Influenza-like illness is defined as the presence of:
    • Fever measured by the patient or physician and at least one of the following symptoms:
    • Sore throat.
    • Coryza (runny nose) and/or nasal congestion.

      • Cough.

      • Availability to be followed up by phone or in person after an interval of approximately 14
    • 21 days.
    Exclusion criteria:

      Receipt of any experimental influenza vaccine within 6 months of the onset of the influenza-like illness.

      • Terminal stage of disease.
      • Subjects living in a nursing home.
      • Use of any investigational or non-registered product planned during the study period.
      • Subjects who have already been enrolled in this study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Curitiba/Paraná, Paraná, Brazil, 80810-050
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-29-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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