A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
perjantai 15. marraskuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
2000
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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-
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Budapest, Unkari, 1136
- GSK Investigational Site
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Budapest, Unkari, 1182
- GSK Investigational Site
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Debrecen, Unkari, 4027
- GSK Investigational Site
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Kecskemét, Unkari, 6000
- GSK Investigational Site
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Zirc, Unkari, 8420
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Muut: Study Group
Subjects, male and female, aged 18 years and above who had agreed to collection of blood sample.
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A blood sample (2.5 mL) will be collected from all subjects
Active questioning
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Aikaikkuna: At the time of enrollment of each subject (Day 0)
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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)
|
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Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: At the time of enrollment of each subject (Day 0)
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The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.
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At the time of enrollment of each subject (Day 0)
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Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
Aikaikkuna: At the time of enrollment of each subject (Day 0)
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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.
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At the time of enrollment of each subject (Day 0)
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Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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.
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At the time of enrollment of each subject (Day 0)
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Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Aikaikkuna: At the time of enrollment of each subject (Day 0)
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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)
|
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Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
|
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Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)
Aikaikkuna: At the time of enrollment of each subject (Day 0)
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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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
|
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Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)
Aikaikkuna: At the time of enrollment of each subject (Day 0)
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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.
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At the time of enrollment of each subject (Day 0)
|
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Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
|
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Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Aikaikkuna: 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.
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At the time of enrollment of each subject (Day 0)
|
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Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 24. huhtikuuta 2014
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 22. huhtikuuta 2015
Opintojen valmistuminen (Todellinen)
Perjantai 24. huhtikuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 12. joulukuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 12. joulukuuta 2013
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 18. joulukuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 26. marraskuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 15. marraskuuta 2019
Viimeksi vahvistettu
Perjantai 1. marraskuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 116804
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
IPD for this study will be made available via the Clinical Study Data Request site.
IPD-jaon aikakehys
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD-jaon käyttöoikeuskriteerit
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-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- CSR
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .