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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01171157
• Other study ID #: 112868
• Status: Terminated
• Start date: May 26, 2009
• Est. completion date: June 29, 2009

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 29, 2009
• Est. primary completion date: June 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Other:
• Routine sample collection
Collection of routine nasal/throat swab samples

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Curitiba/Paraná	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days of illness since onset of influenza-like illness		At the follow-up contact (between day 12 and 28)
Secondary	Number of days of reduced activity since onset of influenza-like illness		At the follow-up contact (between day 12 and 28)
Secondary	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)
Secondary	Number of medical visits related to influenza-like illness since Visit 1		At the follow-up contact (between day 12 and 28)
Secondary	Use of medication since onset of influenza-like illness		At the follow-up contact (between day 12 and 28)
Secondary	Occurrence of complications since onset of influenza-like illness		At the follow-up contact (between day 12 and 28)
Secondary	Hospitalization since onset of influenza-like illness		At the follow-up contact (between day 12 and 28)
Secondary	Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR		At enrolment (day 0)
Secondary	Number of deaths		At the follow-up contact (between day 12 and 28)
Secondary	Clinical features related to influenza-like illness		At enrolment (day 0)