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

This study has been 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)
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 15, 2010
Last updated: May 7, 2015
Last verified: May 2015
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 Intervention
Other: Routine sample collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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) ]

Biospecimen Retention:   Samples With DNA
One nose/throat swab

Enrollment: 4
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects with influenza like illness
Other: Routine sample collection
Collection of routine nasal/throat swab samples


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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01171157

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

Responsible Party: GlaxoSmithKline Identifier: NCT01171157     History of Changes
Other Study ID Numbers: 112868
Study First Received: July 15, 2010
Last Updated: May 7, 2015

Keywords provided by GlaxoSmithKline:
vaccine effectiveness
Influenza-like illness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on May 25, 2017