Trial · NCT02014519
A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
NCT02014519, Not applicable, Completed, GlaxoSmithKline; results first posted 2018-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary. Trials, record NCT02014519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02014519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
- NCT number
- NCT02014519
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,000 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pertussis, Pertussis Vaccines
- Interventions
- Blood sampling, Data collection
- First posted
- 2013-12-18
- Last updated
- 2019-11-26
- Results first posted
- 2018-12-17
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) |
| Primary | 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 |
| Primary | 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. |
| Primary | 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 | 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). |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations | At the time of enrollment of each subject (Day 0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection | At the time of enrollment of each subject (Day 0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seronegative Subjects in Terms of Anti-PT Concentrations | At the time of enrollment of each subject (Day 0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | At the time of enrollment of each subject (Day 0). | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age) | At the time of enrollment of each subject (Day 0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender) | At the time of enrollment of each subject (Day 0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations | Study Group | 295 | Participants | ||
| Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection | Study Group | 2 | Participants | ||
| Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection | Study Group | 22 | Participants | ||
| Number of Seronegative Subjects in Terms of Anti-PT Concentrations | Study Group | 1704 | Participants | ||
| Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 18-29 Years Group | 67 | Participants | ||
| Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 30-44 Years Group | 67 | Participants | ||
| Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | 45-59 Years Group | 56 | Participants | ||
| Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) | ≥ 60 Years Group | 105 | Participants | ||
| Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) | 18-29 Years Group | 0 | Participants | ||
| Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) | 30-44 Years Group | 1 | Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Group | 2,000 | |
| Overall Study | COMPLETED | Study Group | 2,000 | |
| Overall Study | NOT COMPLETED | Study Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Group | 0 | 2,000 |
| Total, other adverse events | Study Group | 0 | 0 |
| Total, serious adverse events | Study Group | 0 | 2,000 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28376739 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Male Group vs Female Group: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender) | Trial comparisons |
| Female Group vs Male Group: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender) | Trial comparisons |
| Female Group vs Male Group: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender) | Trial comparisons |
| Female Group vs Male Group: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender) | Trial comparisons |
| Female Group vs Male Group: Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02014519
GET https://conductscience.org/api/trials/v1/NCT02014519/registered?page=2