N/A
N=2,000
A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
Pertussis · Pertussis Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT02014519 ↗Enrolled (actual)
2,000
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations — 295 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood sampling (Procedure); Data collection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations |
295 | — |
| PRIMARY Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection |
2 | — |
| PRIMARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection |
22 | — |
| PRIMARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations |
1704 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age) |
67; 67; 56; 105 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age) |
0; 1; 1; 0 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age) |
2; 5; 4; 11 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age) |
341; 474; 453; 436 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender) |
160; 135 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender) |
0; 2 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender) |
10; 12 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender) |
1052; 652 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender) |
775; 1202 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) |
240; 30 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough) |
1328; 197 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough) |
17; 4 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough) |
1551; 223 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status) |
136; 86; 73 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status) |
943; 396; 365 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status) |
4; 8; 10 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status) |
1075; 474; 428 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) |
212; 15 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis) |
1266; 73 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis) |
18; 1 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis) |
1460; 87 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) |
38; 127 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis) |
243; 755 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis) |
2; 7 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis) |
279; 875 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication) |
248; 39 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication) |
1473; 202 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication) |
18; 3 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication) |
1703; 238 | — |
| SECONDARY Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization) |
290; 4 | — |
| SECONDARY Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization) |
1694; 6 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization) |
22; 0 | — |
| SECONDARY Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization) |
1962; 10 | — |
Summary
The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02014519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.