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

NCT ID: NCT02014519

Last Updated: 2019-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-24

Study Completion Date

2015-04-24

Brief Summary

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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

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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.

Conditions

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Pertussis Pertussis Vaccines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study Group

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

Group Type OTHER

Blood sampling

Intervention Type PROCEDURE

A blood sample (2.5 mL) will be collected from all subjects

Data collection

Intervention Type OTHER

Active questioning

Interventions

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Blood sampling

A blood sample (2.5 mL) will be collected from all subjects

Intervention Type PROCEDURE

Data collection

Active questioning

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Budapest, , Hungary

Site Status

GSK Investigational Site

Budapest, , Hungary

Site Status

GSK Investigational Site

Debrecen, , Hungary

Site Status

GSK Investigational Site

Kecskemét, , Hungary

Site Status

GSK Investigational Site

Zirc, , Hungary

Site Status

Countries

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Hungary

References

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Torzsa P, Devadiga R, Tafalla M. Seroprevalence of Bordetella pertussis antibodies in adults in Hungary: results of an epidemiological cross-sectional study. BMC Infect Dis. 2017 Apr 4;17(1):242. doi: 10.1186/s12879-017-2356-2.

Reference Type BACKGROUND
PMID: 28376739 (View on PubMed)

Other Identifiers

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116804

Identifier Type: -

Identifier Source: org_study_id

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