We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01171157
Recruitment Status : Terminated (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)
First Posted : July 28, 2010
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Influenza Other: Routine sample collection

Study Design

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : May 2009
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1
Subjects with influenza like illness
Other: Routine sample collection
Collection of routine nasal/throat swab samples


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Number of days of illness since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  2. Number of days of reduced activity since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  3. 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) ]
  4. Number of medical visits related to influenza-like illness since Visit 1 [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  5. Use of medication since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  6. Occurrence of complications since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  7. Hospitalization since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  8. Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR [ Time Frame: At enrolment (day 0) ]
  9. Number of deaths [ Time Frame: At the follow-up contact (between day 12 and 28) ]
  10. Clinical features related to influenza-like illness [ Time Frame: At enrolment (day 0) ]

Biospecimen Retention:   Samples With DNA
One nose/throat swab

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults aged 65 years and over, consulting a physician for an influenza-like illness during the influenza season.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171157


Locations
Brazil
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil, 80810-050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01171157     History of Changes
Other Study ID Numbers: 112868
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by GlaxoSmithKline:
vaccine effectiveness
Influenza-like illness
elderly
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases