Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the context of the World Health Organization's (WHO) Phase 6 pandemic influenza declaration the conduct of the study was deemed no longer feasible
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Subjects with influenza like illness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine sample collection | Other | Collection of routine nasal/throat swab samples |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
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:
Availability to be followed up by phone or in person after an interval of approximately 14 - 21 days.
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults aged 65 years and over, consulting a physician for an influenza-like illness during the influenza season.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Curitiba/ParanĂ¡ | ParanĂ¡ | 80810-050 | Brazil |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
One nose/throat swab
| 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) |
| 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) |
| 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) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |