Last updated: 07/17/2024 16:51:55

A study to determine the seroprevalence of Bordetella pertussis in adults in Hungary

Request patient level data
GSK study ID
116804
See study documents
Clinicaltrials.gov ID
NCT02014519
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Seroprevalence of Bordetella pertussis in adults in Hungary
Trial description: The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of seropositive subjects in terms of anti-pertussis toxin (anti-PT) concentrations

Timeframe: At the time of enrollment of each subject (Day 0)

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)

Number of subjects with anti-PT IgG levels indicative of current/recent infection

Timeframe: At the time of enrollment of each subject (Day 0)

Number of seronegative subjects in terms of anti-PT concentrations

Timeframe: At the time of enrollment of each subject (Day 0)

Secondary outcomes:

Number of seropositive subjects in terms of anti-PT concentrations (by age)

Timeframe: At the time of enrollment of each subject (Day 0).

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)

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)

Number of seronegative subjects in terms of anti-PT concentrations (by age)

Timeframe: At the time of enrollment of each subject (Day 0)

Number of seropositive subjects in terms of anti-PT concentrations (by gender)

Timeframe: At the time of enrollment of each subject (Day 0)

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)

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)

Number of seronegative subjects in terms of anti-PT concentrations (by gender)

Timeframe: At the time of enrollment of each subject (Day 0)

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)

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)

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)

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)

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)

Number of seropositive subjects in terms of anti-PT concentrations (by smoking status)

Timeframe: At the time of enrollment of each subject (Day 0)

Number of seronegative subjects in terms of anti-PT concentrations (by smoking status)

Timeframe: At the time of enrollment of each subject (Day 0)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Number of seropositive subjects in terms of anti-PT concentrations (by medication)

Timeframe: At the time of enrollment of each subject (Day 0)

Number of seronegative subjects in terms of anti-PT concentrations (by medication)

Timeframe: At the time of enrollment of each subject (Day 0)

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)

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)

Number of seropositive subjects in terms of anti-PT concentrations (by hospitalization)

Timeframe: At the time of enrollment of each subject (Day 0)

Number of seronegative subjects in terms of anti-PT concentrations (by hospitalization)

Timeframe: At the time of enrollment of each subject (Day 0)

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)

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)

Interventions:
  • Procedure/surgery: Blood sampling
  • Other: Data collection
    • Enrollment:
    2000
    Primary completion date:
    2015-22-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Torzsa P et al. (2017) Seroprevalence of Bordetella pertussis antibodies in adults in Hungary: results of an epidemiological cross-sectional study. BMC Infect Dis. 17(1):242. doi: 10.1186/s12879-017-2356-2.
    Medical condition
    Pertussis
    Product
    GSK2647153A
    Collaborators
    Not applicable
    Study date(s)
    April 2014 to April 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • Confirmed or suspected immunological disorder.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Budapest, Hungary, 1136
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Debrecen, Hungary, 4027
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kecskemét, Hungary, 6000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Zirc, Hungary, 8420
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-22-04
    Actual study completion date
    2015-24-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website