Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01171157
First received: July 15, 2010
Last updated: November 21, 2012
Last verified: November 2012

July 15, 2010
November 21, 2012
May 2009
June 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01171157 on ClinicalTrials.gov Archive Site
  • Number of days of illness since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Number of days of reduced activity since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Number of days off work of other family members or caregivers to provide patient care since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Number of medical visits related to influenza-like illness since Visit 1 [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Use of medication since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Occurrence of complications since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Hospitalization since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ]
  • Number of deaths [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Clinical features related to influenza-like illness [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ]
  • Number of days of reduced activity since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Number of days off work of other family members or caregivers to provide patient care since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Number of medical visits related to influenza-like illness since Visit 1 [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Use of medication since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Occurrence of complications since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Hospitalization since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ]
  • Number of deaths [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Clinical features related to influenza-like illness [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ]
  • Number of days of illness since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil
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

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).

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

One nose/throat swab

Probability Sample

Adults aged 65 years and over, consulting a physician for an influenza-like illness during the influenza season.

  • Influenza
  • Insufficient Information
Other: Routine sample collection
Collection of routine nasal/throat swab samples
Group 1
Subjects with influenza like illness
Intervention: Other: Routine sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01171157
112868
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP