InfluenzaNCT01171157
Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil
An observational study of Influenza, run by GlaxoSmithKline at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Routine sample collection
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- 26 May 2009to 29 Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults aged 65 years and over, consulting a physician for an influenza-like illness during the influenza season.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Routine sample collection
- Keywords
- Influenza-like illness, vaccine effectiveness, elderly, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine sample collectionOther
Collection of routine nasal/throat swab samples
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects with influenza like illness Receives: Other: Routine sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B
Measured: At enrolment (day 0)
Secondary outcomes (10)
Number of days of illness since onset of influenza-like illness
Measured: At the follow-up contact (between day 12 and 28)
Number of days of reduced activity since onset of influenza-like illness
Measured: 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
Measured: At the follow-up contact (between day 12 and 28)
Number of medical visits related to influenza-like illness since Visit 1
Measured: At the follow-up contact (between day 12 and 28)
Use of medication since onset of influenza-like illness
Measured: At the follow-up contact (between day 12 and 28)
Occurrence of complications since onset of influenza-like illness
Measured: At the follow-up contact (between day 12 and 28)
Hospitalization since onset of influenza-like illness
Measured: 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
Measured: At enrolment (day 0)
Number of deaths
Measured: At the follow-up contact (between day 12 and 28)
Clinical features related to influenza-like illness
Measured: At enrolment (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study start26 May 2009
- Primary completion1 Jun 2009
- Study completion29 Jun 2009
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171157
- Sponsor's protocol ID
- 112868
- Status last verified
- May 2018
- First submitted
- 15 Jul 2010
- Last updated
- 1 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01171157
- Acronym / sponsor ID
- 112868
- Conditions
- Influenza
- Keywords
- Influenza-like illness, vaccine effectiveness, elderly, Influenza
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 May 2009
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 29 Jun 2009 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Routine sample collectionSubjects with influenza like illness |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults aged 65 years and over, consulting a physician for an influenza-like illness during the influenza season.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine sample collectionCollection of routine nasal/throat swab samples | Other | Group 1 |
Primary outcome
Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B
Time frame: At enrolment (day 0)
10 secondary outcomes
Number of days of illness since onset of influenza-like illness
Time frame: At the follow-up contact (between day 12 and 28)
Number of days of reduced activity since onset of influenza-like illness
Time frame: 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
Time frame: At the follow-up contact (between day 12 and 28)
Number of medical visits related to influenza-like illness since Visit 1
Time frame: At the follow-up contact (between day 12 and 28)
Use of medication since onset of influenza-like illness
Time frame: At the follow-up contact (between day 12 and 28)
Occurrence of complications since onset of influenza-like illness
Time frame: At the follow-up contact (between day 12 and 28)
Hospitalization since onset of influenza-like illness
Time frame: 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
Time frame: At enrolment (day 0)
Number of deaths
Time frame: At the follow-up contact (between day 12 and 28)
Clinical features related to influenza-like illness
Time frame: At enrolment (day 0)
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by GlaxoSmithKline at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory-confirmed influenza status in patients presenting with influenza-like illness defined as positive for PCR for influenza A or B (time frame: At enrolment (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.