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

NCT01171157 | Terminated

• 1 other identifier: 112868
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Influenza-like illness; vaccine effectiveness; elderly; Influenza

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  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)

• 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)

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

  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)

Study Arms (1)

Group 1

Subjects with influenza like illness

Other: Routine sample collection

Interventions

Routine sample collection OTHER

Collection of routine nasal/throat swab samples

Group 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Curitiba/Paraná, Paraná, 80810-050, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

One nose/throat swab

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 28, 2010
• Study Start: May 26, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 29, 2009
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

BR (1)