Influenza
Conditions
Keywords
Influenza-like illness, vaccine effectiveness, elderly, Influenza
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).
Interventions
OTHERRoutine sample collection
Collection of routine nasal/throat swab samples
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Number of days of illness 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) |
| Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR | At enrolment (day 0) |
| Number of deaths | At the follow-up contact (between day 12 and 28) |
| Clinical features related to influenza-like illness | At enrolment (day 0) |
| Occurrence of complications since onset of influenza-like illness | At the follow-up contact (between day 12 and 28) |
Countries
Brazil
Outcome results
None listed