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

Seroprevalence of Bordetella Pertussis in Adults in Hungary

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

Study Overview

• Status: Completed
• Conditions: Pertussis; Pertussis Vaccines
• Intervention / Treatment: Procedure: Blood sampling; Other: Data collection

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
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1136
    • GSK Investigational Site
  • Budapest, Hungary, 1182
    • GSK Investigational Site
  • Debrecen, Hungary, 4027
    • GSK Investigational Site
  • Kecskemét, Hungary, 6000
    • GSK Investigational Site
  • Zirc, Hungary, 8420
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Group; Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	Procedure: Blood sampling; A blood sample (2.5 mL) will be collected from all subjects; Other: Data collection; Active questioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection	The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)	At the time of enrollment of each subject (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).	At the time of enrollment of each subject (Day 0).
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)	The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)	The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)	Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.	At the time of enrollment of each subject (Day 0)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2014
• Primary Completion (Actual): April 22, 2015
• Study Completion (Actual): April 24, 2015

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Adults; Seroprevalence; Bordetella pertussis; Pertussis antibodies; Hungary
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough
• Other Study ID Numbers: 116804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR