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

Pertussis Clinical Trial

Official title:

Seroprevalence of Bordetella Pertussis in Adults in Hungary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014519
• Other study ID #: 116804
• Status: Completed
• Phase: N/A
• Start date: April 24, 2014
• Est. completion date: April 24, 2015

Study information

• Verified date: November 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: April 24, 2015
• Est. primary completion date: April 22, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pertussis
• Pertussis Vaccines
• Whooping Cough

Intervention

Procedure:
• Blood sampling
A blood sample (2.5 mL) will be collected from all subjects

Other:
• Data collection
Active questioning

Locations

Country	Name	City	State
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Kecskemét
Hungary	GSK Investigational Site	Zirc

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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).
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)