A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary
15 novembre 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
2000
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Budapest, Hongrie, 1136
- GSK Investigational Site
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Budapest, Hongrie, 1182
- GSK Investigational Site
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Debrecen, Hongrie, 4027
- GSK Investigational Site
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Kecskemét, Hongrie, 6000
- GSK Investigational Site
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Zirc, Hongrie, 8420
- GSK Investigational Site
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 avril 2014
Achèvement primaire (Réel)
22 avril 2015
Achèvement de l'étude (Réel)
24 avril 2015
Dates d'inscription aux études
Première soumission
12 décembre 2013
Première soumission répondant aux critères de contrôle qualité
12 décembre 2013
Première publication (Estimation)
18 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 novembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 novembre 2019
Dernière vérification
1 novembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 116804
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Description du régime IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Délai de partage IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .