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Completed

NCT Number: NCT02014519

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

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

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Key information

Conditions

Pertussis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Pertussis Vaccines Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sampling

Procedure

A blood sample (2.5 mL) will be collected from all subjects

Data Collection

Other

Active questioning

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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 outcomes

  1. 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).

  2. 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

  3. 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.

  4. 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 under the sensitivity limit of the assay (≤ 0.3 OD units)

  5. 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)

  6. 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

  7. 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.

  8. 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 under the sensitivity limit of the assay (≤ 0.3 OD units)

  9. 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 not indicative of current/recent infection was smaller than (<) 1.0 OD units.

  10. 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.

  11. 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 under 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.

  12. 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.

  13. 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 not indicative of current/recent infection was smaller than (<) 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.

  14. 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)

  15. 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 under the sensitivity limit of the assay (≤ 0.3 OD units)

  16. 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.

  17. 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 not indicative of current/recent infection was smaller than (<) 1.0 OD units.

  18. 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)

  19. 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 under the sensitivity limit of the assay (≤ 0.3 OD units)

  20. 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.

  21. 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 not indicative of current/recent infection was smaller than (<) 1.0 OD units.

  22. 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)

  23. 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 under the sensitivity limit of the assay (≤ 0.3 OD units)

  24. 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.

  25. 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.

  26. 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.

  27. 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 under 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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 under 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.

  32. 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.

  33. 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 not 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Seroprevalence of Bordetella Pertussis in Adults in Hungary

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2013
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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