Clinical trial NCT02014519: A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
Official title: Seroprevalence of Bordetella Pertussis in Adults in Hungary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pertussis
Pertussis Vaccines
Keywords: Adults
Hungary
Bordetella pertussis
Seroprevalence
Pertussis antibodies
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-12-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations
timeFrame: At the time of enrollment of each subject (Day 0)
Secondary outcomes:
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
timeFrame: At the time of enrollment of each subject (Day 0).
measure: Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)
timeFrame: At the time of enrollment of each subject (Day 0)
measure: Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)
timeFrame: At the time of enrollment of each subject (Day 0)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Kecskemét
country: Hungary
facility: GSK Investigational Site
city: Zirc
country: Hungary
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Torzsa P, Devadiga R, Tafalla M. Seroprevalence of Bordetella pertussis antibodies in adults in Hungary: results of an epidemiological cross-sectional study. BMC Infect Dis. 2017 Apr 4;17(1):242. doi: 10.1186/s12879-017-2356-2.