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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Other | Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | A blood sample (2.5 mL) will be collected from all subjects |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
• Confirmed or suspected immunological disorder.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Budapest | 1136 | Hungary | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28376739 | Background | 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. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
|
|
Day 0 (all study procedures were performed and completed at the first and only visit in this study)
Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Data collection |
| Other |
Active questioning |
|
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) |
| Budapest |
| 1182 |
| Hungary |
| GSK Investigational Site | Debrecen | 4027 | Hungary |
| GSK Investigational Site | Kecskemét | 6000 | Hungary |
| GSK Investigational Site | Zirc | 8420 | Hungary |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 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 | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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). | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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 | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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 | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis. | Posted | Count of Participants | Participants | 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) | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis. | Posted | Count of Participants | Participants | 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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|
|
| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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| 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. | The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history. | Posted | Count of Participants | Participants | At the time of enrollment of each subject (Day 0) |
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|
|
| 0 |
| 2,000 |
| 0 |
| 2,000 |
| 0 |
| 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Current Smoker |
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| Current Smoker |
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| Current Smoker |
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| Current Smoker |
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