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A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02014519
First received: December 12, 2013
Last updated: May 22, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to perform a epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

Condition Intervention
Pertussis
Procedure: Blood sampling
Other: Data collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Seroprevalence of Bordetella Pertussis in Adults in Hungary

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of seropositive subjects in terms of anti-pertussis toxin (anti-PT) concentrations [ Time Frame: 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)

  • Number of subjects with anti-PT IgG levels strongly indicative of current/recent infection [ Time Frame: 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

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection [ Time Frame: 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.

  • Number of seronegative subjects in terms of anti-PT concentrations [ Time Frame: 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 Outcome Measures:
  • Number of seropositive subjects in terms of anti-PT concentrations (by age) [ Time Frame: 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).

  • Number of subjects with anti-PT IgG levels strongly indicative of current/recent infection (by age) [ Time Frame: 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

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by age) [ Time Frame: 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.

  • Number of seronegative subjects in terms of anti-PT concentrations (by age) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≥ 0.3 OD units)

  • Number of seropositive subjects in terms of anti-PT concentrations (by gender) [ Time Frame: 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)

  • Number of subjects with anti-PT IgG levels strongly indicative of current/recent infection (by gender) [ Time Frame: 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

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by gender) [ Time Frame: 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.

  • Number of seronegative subjects in terms of anti-PT concentrations (by gender) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≥ 0.3 OD units)

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by gender) [ Time Frame: 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 smaller than (<) 1.0 OD units.

  • Number of seropositive subjects in terms of anti-PT concentrations (by recent history of long-lasting cough) [ Time Frame: 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). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

  • Number of seronegative subjects in terms of anti-PT concentrations (by recent history of long-lasting cough) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≥ 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by recent history of long-lasting cough) [ Time Frame: 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. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by recent history of long-lasting cough) [ Time Frame: 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 smaller than or equal to (≤) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.

  • Number of seropositive subjects in terms of anti-PT concentrations (by smoking status) [ Time Frame: 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)

  • Number of seronegative subjects in terms of anti-PT concentrations (by smoking status) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≤ 0.3 OD units)

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by smoking status) [ Time Frame: 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.

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by smoking status) [ Time Frame: 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 smaller than (<) 1.0 OD units.

  • Number of seropositive subjects in terms of anti-PT concentrations (by history of pertussis) [ Time Frame: 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)

  • Number of seronegative subjects in terms of anti-PT concentrations (by history of pertussis) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≤ 0.3 OD units)

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by history of pertussis) [ Time Frame: 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.

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by history of pertussis) [ Time Frame: 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 smaller than (<) 1.0 OD units.

  • Number of seropositive subjects in terms of anti-PT concentrations (by history of vaccination against pertussis) [ Time Frame: 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)

  • Number of seronegative subjects in terms of anti-PT concentrations (by history of vaccination against pertussis) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≤ 0.3 OD units)

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by history of vaccination against pertussis) [ Time Frame: 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.

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by history of vaccination against pertussis) [ Time Frame: 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 smaller than (<) 1.0 OD units.

  • Number of seropositive subjects in terms of anti-PT concentrations (by medication) [ Time Frame: 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). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

  • Number of seronegative subjects in terms of anti-PT concentrations (by medication) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≤ 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by medication) [ Time Frame: 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. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by medication) [ Time Frame: 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 smaller than (<) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.

  • Number of seropositive subjects in terms of anti-PT concentrations (by hospitalization) [ Time Frame: 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). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

  • Number of seronegative subjects in terms of anti-PT concentrations (by hospitalization) [ Time Frame: At the time of enrollment of each subject (Day 0) ]
    Seronegativity was defined as anti-PT IgG levels above the sensitivity limit of the assay (≤ 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

  • Number of subjects with anti-PT IgG levels indicative of current/recent infection (by hospitalization) [ Time Frame: 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. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.

  • Number of subjects with anti-PT IgG levels not indicative of current/recent infection (by hospitalization) [ Time Frame: 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 smaller than (<) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.


Enrollment: 2000
Actual Study Start Date: April 24, 2014
Study Completion Date: April 24, 2015
Primary Completion Date: April 22, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Study Group
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
Procedure: Blood sampling
A blood sample (2.5 mL) will be collected from all subjects
Other: Data collection
Active questioning

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014519

Locations
Hungary
GSK Investigational Site
Budapest, Hungary, 1136
GSK Investigational Site
Budapest, Hungary, 1182
GSK Investigational Site
Debrecen, Hungary, 4027
GSK Investigational Site
Kecskemét, Hungary, 6000
GSK Investigational Site
Zirc, Hungary, 8420
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02014519     History of Changes
Other Study ID Numbers: 116804
Study First Received: December 12, 2013
Last Updated: May 22, 2017

Keywords provided by GlaxoSmithKline:
Adults
Hungary
Bordetella pertussis
Seroprevalence
Pertussis antibodies

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 25, 2017