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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02014519
First received: December 12, 2013
Last updated: October 2, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Pertussis
Procedure: Blood sampling
Other: Data collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Seroprevalence of Bordetella Pertussis in Adults in Hungary

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adult Group
Not Applicable.
Procedure: Blood sampling
A blood sample (2.5 mL) will be collected from all subjects
Other: Data collection
Active questioning

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  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: NCT02014519

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Hungary
GSK Investigational Site Recruiting
Budapest, Hungary, 1182
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Budapest, Hungary, 1136
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Kecskemét, Hungary, 6000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Zirc, Hungary, 8420
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02014519     History of Changes
Other Study ID Numbers: 116804
Study First Received: December 12, 2013
Last Updated: October 2, 2014
Health Authority: Hungary: Human Resources Ministry

Keywords provided by GlaxoSmithKline:
Seroprevalence
Bordetella pertussis
Pertussis antibodies
Adults
Hungary

Additional relevant MeSH terms:
Whooping Cough
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 21, 2014