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

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

GSK study ID
116804
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2015-22-04
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.

Trial location(s)

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

Study documents

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

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
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
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