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

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Brief Title

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

Official Title

Seroprevalence of Bordetella Pertussis in Adults in Hungary

Brief Summary

      The purpose of this study is to perform an epidemiological survey of the adult population in
      Hungary to calculate the seroprevalence of pertussis.

Detailed Description

      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.

Study Type

Interventional

Primary Outcome

Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations

Secondary Outcome

 Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)

Condition

Pertussis

Intervention

Blood sampling

Study Arms / Comparison Groups

 Study Group
Description:  Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

2000

Start Date

April 24, 2014

Completion Date

April 24, 2015

Primary Completion Date

April 22, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  Written informed consent will be obtained from subjects prior to performing any study
             procedures.

          -  Males or females ≥ 18 years of age at the time of enrollment.

          -  Agreeing to collection of a blood sample for the study.

        Exclusion Criteria:

        • Confirmed or suspected immunological disorder.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

GSK Clinical Trials, ,

Location Countries

Hungary

Location Countries

Hungary

Administrative Informations

NCT ID

NCT02014519

Organization ID

116804

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline

Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline

Verification Date

November 2019