A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
15 listopada 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
2000
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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-
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Budapest, Węgry, 1136
- GSK Investigational Site
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Budapest, Węgry, 1182
- GSK Investigational Site
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Debrecen, Węgry, 4027
- GSK Investigational Site
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Kecskemét, Węgry, 6000
- GSK Investigational Site
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Zirc, Węgry, 8420
- GSK Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
24 kwietnia 2014
Zakończenie podstawowe (Rzeczywisty)
22 kwietnia 2015
Ukończenie studiów (Rzeczywisty)
24 kwietnia 2015
Daty rejestracji na studia
Pierwszy przesłany
12 grudnia 2013
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 grudnia 2013
Pierwszy wysłany (Oszacować)
18 grudnia 2013
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 listopada 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
15 listopada 2019
Ostatnia weryfikacja
1 listopada 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 116804
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Ramy czasowe udostępniania IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .