Clinical Trial: A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Seroprevalence of Bordetella Pertussis in Adults in Hungary

Brief Summary: The purpose of this study is to perform a epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

Detailed Summary: The protocol posting was amended to correct the detailed title. Since a sample of blood will be collected from all subjects (outside of routine hospital procedure), the study does not meet GSK's definition of an observational study and hence the term "observational" was deleted from the detailed title.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Seroprevalence of Bordetella pertussis antibodies among adults aged 18 years and above with respect to anti- Pertussis Toxin (PT) antibody levels, anti-PT seropositivity status and anti-PT seronegativity status. [ Time Frame: At the time of enrollment of each subject (Day 0). ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Seroprevalence of Bordetella pertussis antibodies in individual age-groups (18-29 years, 30-44 years, 45-59 years and ≥ 60 years) with respect to anti-PT antibody levels, anti-PT seropositivity status and anti-PT seronegativity status. [ Time Frame: At the time of enrollment of each subject (Day 0). ]
  • Seroprevalence of Bordetella pertussis antibodies in adults aged 18 years and above with respect to anti-PT antibody levels suggesting recent infection and anti-PT antibody levels not suggesting recent infection. [ Time Frame: At the time of enrollment of each subject (Day 0). ]
    By gender; By recent history of long-lasting cough; By smoking status; By history of pertussis; By history of vaccination against pertussis; By medication and hospitalisation due to respiratory infections in the previous 12 months.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: December 12, 2013
Date Started: April 2014
Date Completion:
Last Updated: January 14, 2016
Last Verified: January 2016