PertussisNCT02014519
A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
A study testing Blood sampling and Data collection in people with Pertussis and Pertussis Vaccines, run by GlaxoSmithKline at 5 sites in Hungary.
Trial summary
The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Pertussis Vaccines
- What is being tested?
- Blood sampling and Data collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 5 sitesHungary
- Study dates
- 24 Apr 2014to 24 Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Confirmed or suspected immunological disorder.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Hungary5 sites
GSK Investigational Site
Budapest, 1136
GSK Investigational Site
Budapest, 1182
GSK Investigational Site
Debrecen, 4027
GSK Investigational Site
Kecskemét, 6000
GSK Investigational Site
Zirc, 8420
About this study
Official title: 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.
Read the 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.
- Conditions
- Pertussis, Pertussis Vaccines
- Being tested
- Blood sampling, Data collection
- Keywords
- Adults, Hungary, Bordetella pertussis, Seroprevalence, Pertussis antibodies
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
A blood sample (2.5 mL) will be collected from all subjects
Data collectionOther
Active questioning
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Other | Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample. Receives: Procedure: Blood sampling; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)
Measured: At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
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
Measured: At the time of enrollment of each subject (Day 0)
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Measured: At the time of enrollment of each subject (Day 0)
Secondary outcomes (33)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).
Measured: 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)
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
Measured: 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)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Measured: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Measured: 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)
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
Measured: 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)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Measured: 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)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Measured: 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)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Measured: 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)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Measured: 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)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Measured: 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)
The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
Measured: 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)
Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)
Measured: 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)
Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)
Measured: 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)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.
Measured: 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)
The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
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.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
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.
Measured: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: At the time of enrollment of each subject (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study start24 Apr 2014
- Primary completion22 Apr 2015
- Study completion24 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014519
- Sponsor's protocol ID
- 116804
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2013
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
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.
PubMed 28376739
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Bordetella Pertussis in Adults in Hungary
- ClinicalTrials.gov ID
- NCT02014519
- Acronym / sponsor ID
- 116804
- Conditions
- Pertussis, Pertussis Vaccines
- Keywords
- Adults, Hungary, Bordetella pertussis, Seroprevalence, Pertussis antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2014 (actual)
- Primary completion
- 22 Apr 2015 (actual)
- Study completion
- 24 Apr 2015 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Other | Procedure: Blood sampling, Other: Data collectionSubjects, male and female, aged 18 years and above who had agreed to collection of blood sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Confirmed or suspected immunological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingA blood sample (2.5 mL) will be collected from all subjects | Procedure or surgery | Study Group |
| Data collectionActive questioning | Other | Study Group |
Primary outcome
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)
33 secondary outcomes
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Time frame: 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)
Time frame: 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)
Time frame: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
Time frame: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
Time frame: 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)
Time frame: 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)
Time frame: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At the time of enrollment of each subject (Day 0)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
Time frame: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
Time frame: 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)
Time frame: 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)
Time frame: At the time of enrollment of each subject (Day 0)
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Time frame: At the time of enrollment of each subject (Day 0)
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Time frame: 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)
Time frame: 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)
Time frame: At the time of enrollment of each subject (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28376739Torzsa 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.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Data collection in people with Pertussis and Pertussis Vaccines, run by GlaxoSmithKline at 5 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.