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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01171157
First received: July 15, 2010
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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
Influenza
Insufficient Information
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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • Number of days of reduced activity since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of medical visits related to influenza-like illness since Visit 1 [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Use of medication since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Occurrence of complications since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Hospitalization since onset of influenza-like illness [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Presence of non-influenza respiratory pathogens in patients presenting with influenza-like illness defined as positivity by PCR [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ]
  • Number of deaths [ Time Frame: At the follow-up contact (between day 12 and 28) ] [ Designated as safety issue: No ]
  • Clinical features related to influenza-like illness [ Time Frame: At enrolment (day 0) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01171157     History of Changes
Other Study ID Numbers: 112868
Study First Received: July 15, 2010
Last Updated: November 21, 2012
Health Authority: Brazil: ANVISA

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

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

ClinicalTrials.gov processed this record on October 23, 2014