Pertussis, Pertussis Vaccines
Conditions
Keywords
Adults, Hungary, Bordetella pertussis, Seroprevalence, Pertussis antibodies
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.
Interventions
PROCEDUREBlood sampling
A blood sample (2.5 mL) will be collected from all subjects
OTHERData collection
Active questioning
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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. |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample. | 2,000 |
| Total | 2,000 |
Baseline characteristics
| Characteristic | Study Group | — |
|---|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 17.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1213 Participants | — |
| Sex: Female, Male Male | 787 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,000 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 2,000 |
Outcome results
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations | 1704 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations | 295 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection | 22 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
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection | 2 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age) | 341 Participants |
| 30-44 Years Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age) | 474 Participants |
| 45-59 Years Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age) | 453 Participants |
| ≥ 60 Years Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age) | 436 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender) | 1052 Participants |
| 30-44 Years Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender) | 652 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) | Without history of Pertussis | 1266 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) | With history of Pertussis | 73 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) | Without history of vaccination against Pertussis | 243 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) | With history of vaccination against Pertussis | 755 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization) | Without history of hospitalization | 1694 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization) | With history of hospitalization | 6 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication) | Without history of medication | 1473 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication) | With history of medication | 202 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) | Without long-lasting cough | 1328 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) | With long-lasting cough | 197 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) | Never Smoker | 943 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) | Former Smoker | 396 Participants |
| Study Group | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) | Current Smoker | 365 Participants |
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).
Time frame: At the time of enrollment of each subject (Day 0).
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 67 Participants |
| 30-44 Years Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 67 Participants |
| 45-59 Years Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 56 Participants |
| ≥ 60 Years Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 105 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender) | 160 Participants |
| 30-44 Years Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender) | 135 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) | Without history of Pertussis | 212 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) | With history of Pertussis | 15 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) | Without history of vaccination against Pertussis | 38 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) | With history of vaccination against Pertussis | 127 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization) | Without history of hospitalization | 290 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization) | With history of hospitalization | 4 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication) | Without history of medication | 248 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication) | With history of medication | 39 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) | Without long-lasting cough | 240 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) | With long-lasting cough | 30 Participants |
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)
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) | Never Smoker | 136 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) | Former Smoker | 86 Participants |
| Study Group | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) | Current Smoker | 73 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age) | 2 Participants |
| 30-44 Years Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age) | 5 Participants |
| 45-59 Years Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age) | 4 Participants |
| ≥ 60 Years Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age) | 11 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender) | 10 Participants |
| 30-44 Years Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender) | 12 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis) | Without history of Pertussis | 18 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis) | With history of Pertussis | 1 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis) | Without history of vaccination against Pertussis | 2 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis) | With history of vaccination against Pertussis | 7 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization) | Without history of hospitalization | 22 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization) | With history of hospitalization | 0 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication) | Without history of medication | 18 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication) | With history of medication | 3 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough) | Without long-lasting cough | 17 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough) | With long-lasting cough | 4 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) | Never Smoker | 4 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) | Former Smoker | 8 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) | Current Smoker | 10 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender) | 775 Participants |
| 30-44 Years Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender) | 1202 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis) | Without history of Pertussis | 1460 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis) | With history of Pertussis | 87 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis) | Without history of vaccination against Pertussis | 279 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis) | With history of vaccination against Pertussis | 875 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization) | Without history of hospitalization | 1962 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization) | With history of hospitalization | 10 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication) | Without Medication | 1703 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication) | With Medication | 238 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough) | Without long-lasting cough | 1551 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough) | With long-lasting cough | 223 Participants |
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.
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) | Never Smoker | 1075 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) | Former Smoker | 474 Participants |
| Study Group | Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) | Current Smoker | 428 Participants |
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
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) | 0 Participants |
| 30-44 Years Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) | 1 Participants |
| 45-59 Years Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) | 1 Participants |
| ≥ 60 Years Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) | 0 Participants |
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
Time frame: At the time of enrollment of each subject (Day 0)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender) | 0 Participants |
| 30-44 Years Group | Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender) | 2 Participants |