A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
15. november 2019 opdateret af: GlaxoSmithKline
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Budapest, Ungarn, 1136
- GSK Investigational Site
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Budapest, Ungarn, 1182
- GSK Investigational Site
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Debrecen, Ungarn, 4027
- GSK Investigational Site
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Kecskemét, Ungarn, 6000
- GSK Investigational Site
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Zirc, Ungarn, 8420
- GSK Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Study Group
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
|
A blood sample (2.5 mL) will be collected from all subjects
Active questioning
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Tidsramme: 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)
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
Tidsramme: 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
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations
Tidsramme: 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)
|
At the time of enrollment of each subject (Day 0)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Tidsramme: 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).
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)
Tidsramme: 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)
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)
Tidsramme: 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)
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)
Tidsramme: 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)
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Tidsramme: 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)
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Tidsramme: 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)
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Tidsramme: 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)
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Tidsramme: 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)
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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)
|
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)
Tidsramme: 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)
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
|
Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
At the time of enrollment of each subject (Day 0)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. april 2014
Primær færdiggørelse (Faktiske)
22. april 2015
Studieafslutning (Faktiske)
24. april 2015
Datoer for studieregistrering
Først indsendt
12. december 2013
Først indsendt, der opfyldte QC-kriterier
12. december 2013
Først opslået (Skøn)
18. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 116804
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD for this study will be made available via the Clinical Study Data Request site.
IPD-delingstidsramme
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD-delingsadgangskriterier
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .