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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Seroprevalence of Bordetella Pertussis in Adults in Hungary

Conditions
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Pertussis, Pertussis Vaccines

Intervention / Treatment
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* Procedure: Blood sampling
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, Hungary, Bordetella pertussis, Seroprevalence, Pertussis antibodies