Back to resultsA Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
Primary Purpose
Pertussis, Pertussis Vaccines
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Blood sampling
Data collection
Sponsored by
About this trial
This is an interventional other trial for Pertussis focused on measuring Adults, Hungary, Bordetella pertussis, Seroprevalence, Pertussis antibodies
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study Group
Arm Description
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Outcomes
Primary Outcome Measures
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)
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
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.
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)
Secondary Outcome Measures
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).
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
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.
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)
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)
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
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.
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)
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.
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.
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.
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.
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.
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)
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)
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.
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.
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)
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)
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.
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.
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02014519
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2014 (Actual)
Primary Completion Date
April 22, 2015 (Actual)
Study Completion Date
April 24, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis, Pertussis Vaccines
Keywords
Adults, Hungary, Bordetella pertussis, Seroprevalence, Pertussis antibodies
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Other
Arm Description
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
A blood sample (2.5 mL) will be collected from all subjects
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
Active questioning
Primary Outcome Measure Information:
Title
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Description
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
Description
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
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations
Description
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Secondary Outcome Measure Information:
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Description
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).
Time Frame
At the time of enrollment of each subject (Day 0).
Title
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)
Description
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
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
Description
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
Description
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)
Description
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
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
Description
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)
Description
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Description
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Description
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)
Description
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Description
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Description
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)
Description
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
Description
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
Description
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
Description
The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
Title
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)
Description
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.
Time Frame
At the time of enrollment of each subject (Day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1182
Country
Hungary
Facility Name
GSK Investigational Site
City
Debrecen
ZIP/Postal Code
4027
Country
Hungary
Facility Name
GSK Investigational Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
GSK Investigational Site
City
Zirc
ZIP/Postal Code
8420
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=116804
Citations:
PubMed Identifier
28376739
Citation
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.
Results Reference
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Learn more about this trial
A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
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