A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
15 novembre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
2000
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Budapest, Ungheria, 1136
- GSK Investigational Site
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Budapest, Ungheria, 1182
- GSK Investigational Site
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Debrecen, Ungheria, 4027
- GSK Investigational Site
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Kecskemét, Ungheria, 6000
- GSK Investigational Site
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Zirc, Ungheria, 8420
- GSK Investigational Site
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
24 aprile 2014
Completamento primario (Effettivo)
22 aprile 2015
Completamento dello studio (Effettivo)
24 aprile 2015
Date di iscrizione allo studio
Primo inviato
12 dicembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
12 dicembre 2013
Primo Inserito (Stima)
18 dicembre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 novembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 novembre 2019
Ultimo verificato
1 novembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 116804
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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Descrizione del piano IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Periodo di condivisione IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .