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

NCT ID: NCT01171157

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-26
• Study Completion Date: 2009-06-29

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).

Conditions

Influenza

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Subjects with influenza like illness

Routine sample collection

Intervention Type: OTHER

Collection of routine nasal/throat swab samples

Interventions

Routine sample collection

Collection of routine nasal/throat swab samples

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Curitiba/Paraná, Paraná, Brazil

Countries

Brazil

Other Identifiers

112868

Identifier Type: -

Identifier Source: org_study_id