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
Discontinued
Discontinued
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
Observational study model:
Case-Control
Primary completion date:
Not applicable
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
Discontinued
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
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Access to clinical trial data by researchers
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