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

Not Applicable

Completed

Conditions: Pertussis
Pertussis Vaccines

Interventions: Procedure: Blood sampling
Other: Data collection

Registration Number: NCT02014519

Lead Sponsor: GlaxoSmithKline

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2000

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Data collection	Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Study Group	Blood sampling	Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.

Primary Outcome Measures

Name	Time	Method
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations	At the time of enrollment of each subject (Day 0)	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 Indicative of Current/Recent Infection	At the time of enrollment of each subject (Day 0)	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	At the time of enrollment of each subject (Day 0)	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 Strongly Indicative of Current/Recent Infection	At the time of enrollment of each subject (Day 0)	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

Secondary Outcome Measures

Name	Time	Method
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)	At the time of enrollment of each subject (Day 0)	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 History of Pertussis)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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 Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)	At the time of enrollment of each subject (Day 0)	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 Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)	At the time of enrollment of each subject (Day 0).	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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 Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)	At the time of enrollment of each subject (Day 0)	Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 OD units)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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 History of Vaccination Against Pertussis)	At the time of enrollment of each subject (Day 0)	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 Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)	At the time of enrollment of each subject (Day 0)	The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (\<) 1.0 OD units.
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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 Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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 Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (\<) 1.0 OD units.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)	At the time of enrollment of each subject (Day 0)	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 Hospitalization)	At the time of enrollment of each subject (Day 0)	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 Medication)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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 Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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)	At the time of enrollment of each subject (Day 0)	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.