Trial Outcomes & Findings for A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary (NCT NCT02014519)

NCT ID: NCT02014519

Last Updated: 2019-11-26

Results Overview

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (\> 0.3 Optical Density (OD) units)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2000 participants
• Primary outcome timeframe: At the time of enrollment of each subject (Day 0)
• Results posted on: 2019-11-26

Participant Flow

Participant milestones

Measure	Study Group Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Overall Study STARTED	2000
Overall Study COMPLETED	2000
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Study Group n=2000 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Age, Continuous	47.4 years STANDARD_DEVIATION 17.7 • n=2000 Participants
Sex: Female, Male Female	1213 Participants n=2000 Participants
Sex: Female, Male Male	787 Participants n=2000 Participants

PRIMARY outcome

Timeframe: 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.

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations	295 Participants	—	—	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection	2 Participants	—	—	—

PRIMARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection	22 Participants	—	—	—

PRIMARY outcome

Timeframe: 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.

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations	1704 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).

Outcome measures

Measure	Study Group n=408 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=541 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group n=509 Participants Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group n=541 Participants Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)	67 Participants	67 Participants	56 Participants	105 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Study Group n=408 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=541 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group n=509 Participants Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group n=541 Participants Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Outcome measures

Measure	Study Group n=408 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=541 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group n=509 Participants Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group n=541 Participants Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)	2 Participants	5 Participants	4 Participants	11 Participants

SECONDARY outcome

Timeframe: 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.

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Outcome measures

Measure	Study Group n=408 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=541 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group n=509 Participants Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group n=541 Participants Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)	341 Participants	474 Participants	453 Participants	436 Participants

SECONDARY outcome

Timeframe: 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.

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)

Outcome measures

Measure	Study Group n=1212 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=787 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)	160 Participants	135 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Study Group n=1212 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=787 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)	0 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Outcome measures

Measure	Study Group n=1212 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=787 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)	10 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Outcome measures

Measure	Study Group n=1212 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=787 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)	1052 Participants	652 Participants	—	—

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.

Outcome measures

Measure	Study Group n=787 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group n=1212 Participants Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)	775 Participants	1202 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1795 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) Without long-lasting cough	240 Participants	—	—	—
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) With long-lasting cough	30 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1795 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) Without long-lasting cough	1328 Participants	—	—	—
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) With long-lasting cough	197 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1795 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
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	—	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1795 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
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	—	—	—
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 outcome

Timeframe: 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.

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) Never Smoker	136 Participants	—	—	—
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) Former Smoker	86 Participants	—	—	—
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) Current Smoker	73 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) Never Smoker	943 Participants	—	—	—
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) Former Smoker	396 Participants	—	—	—
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) Current Smoker	365 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) Never Smoker	4 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) Former Smoker	8 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) Current Smoker	10 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.

Outcome measures

Measure	Study Group n=1999 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) Never Smoker	1075 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) Former Smoker	474 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) Current Smoker	428 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)

Outcome measures

Measure	Study Group n=1566 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) Without history of Pertussis	212 Participants	—	—	—
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) With history of Pertussis	15 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Outcome measures

Measure	Study Group n=1566 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) Without history of Pertussis	1266 Participants	—	—	—
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) With history of Pertussis	73 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Outcome measures

Measure	Study Group n=1566 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis) Without history of Pertussis	18 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis) With history of Pertussis	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.

Outcome measures

Measure	Study Group n=1566 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis) Without history of Pertussis	1460 Participants	—	—	—
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 outcome

Timeframe: 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.

Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)

Outcome measures

Measure	Study Group n=1163 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) Without history of vaccination against Pertussis	38 Participants	—	—	—
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 outcome

Timeframe: 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.

Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)

Outcome measures

Measure	Study Group n=1163 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) Without history of vaccination against Pertussis	243 Participants	—	—	—
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 outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.

Outcome measures

Measure	Study Group n=1163 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
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	—	—	—
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 outcome

Timeframe: 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.

The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.

Outcome measures

Measure	Study Group n=1163 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
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	—	—	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1962 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication) Without history of medication	248 Participants	—	—	—
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication) With history of medication	39 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1962 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication) Without history of medication	1473 Participants	—	—	—
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication) With history of medication	202 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1962 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication) Without history of medication	18 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication) With history of medication	3 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1962 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication) Without Medication	1703 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication) With Medication	238 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1994 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization) Without history of hospitalization	290 Participants	—	—	—
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization) With history of hospitalization	4 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1994 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization) Without history of hospitalization	1694 Participants	—	—	—
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization) With history of hospitalization	6 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1994 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization) Without history of hospitalization	22 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization) With history of hospitalization	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Study Group n=1994 Participants Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.	30-44 Years Group Subjects, male and female, aged 30-44 years at the time of enrollment, who had agreed to collection of blood sample.	45-59 Years Group Subjects, male and female, aged 45-59 years at the time of enrollment, who had agreed to collection of blood sample.	≥ 60 Years Group Subjects, male and female, aged 60 years and above at the time of enrollment, who had agreed to collection of blood sample.
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization) Without history of hospitalization	1962 Participants	—	—	—
Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization) With history of hospitalization	10 Participants	—	—	—

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER