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

Terminated

• Conditions: Influenza
• Interventions: Other: Routine sample collection

• Registration Number: NCT01171157
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Primary Completion: 2009-06-01
• Study Completion: 2009-06-29
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Routine sample collection	Subjects with influenza like illness

Primary Outcome Measures

Name	Time	Method
Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B	At enrolment (day 0)

Secondary Outcome Measures

Name	Time	Method
Number of medical visits related to influenza-like illness since Visit 1	At the follow-up contact (between day 12 and 28)
Number of days of reduced activity since onset of influenza-like illness	At the follow-up contact (between day 12 and 28)
Clinical features related to influenza-like illness	At enrolment (day 0)
Number of days of illness since onset of influenza-like illness	At the follow-up contact (between day 12 and 28)
Use of medication since onset of influenza-like illness	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	At enrolment (day 0)
Number of days off work of other family members or caregivers to provide patient care since onset of influenza-like illness	At the follow-up contact (between day 12 and 28)
Occurrence of complications since onset of influenza-like illness	At the follow-up contact (between day 12 and 28)
Hospitalization since onset of influenza-like illness	At the follow-up contact (between day 12 and 28)
Number of deaths	At the follow-up contact (between day 12 and 28)

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇷 Curitiba/Paraná, Paraná, Brazil