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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pertussis; Pertussis Vaccines

Treatments: Procedure: Blood sampling; Other: Data collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02014519

116804

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Study Group

Other group

Description:

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

Treatment:

Procedure: Blood sampling

Other: Data collection