ID

12429

Description

Evaluation of the Long-term Persistence of Hepatitis A Antibodies in Healthy Adults Who Were Vaccinated 21-25 Years Earlier With GlaxoSmithKline (GSK) Biologicals' Hepatitis A Vaccine, Havrix®; ODM derived from: https://clinicaltrials.gov/show/NCT02124785

Lien

https://clinicaltrials.gov/show/NCT02124785

Mots-clés

  1. 17/11/2015 17/11/2015 -
  2. 17/11/2015 17/11/2015 - Julian Varghese
Téléchargé le

17 novembre 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Hepatitis A NCT02124785

Eligibility Hepatitis A NCT02124785

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female who received two doses of havrix in study hav-112 (208109/108) or hav-123 (208109/114), and received no further booster dose since then.
Description

Havrix therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0700881
subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
Description

compliance

Type de données

boolean

Alias
UMLS CUI [1]
C1321605
written informed consent obtained from the subject.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of hepatitis a disease since completion of the primary vaccination series in studies hav-112 (208109/108) or hav-123 (208109/114).
Description

History of hepatitis

Type de données

boolean

Alias
UMLS CUI [1]
C1997459
administration of a hepatitis a vaccine at any time since completion of the primary vaccination series in studies hav-112 (208109/108) or hav-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
Description

Hepatitis A Vaccines

Type de données

boolean

Alias
UMLS CUI [1]
C0170300
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
Description

Immunosuppressive or immunodeficient condition

Type de données

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0021051
administration of hepatitis a immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
Description

Hepatitis A immunoglobulin

Type de données

boolean

Alias
UMLS CUI [1]
C3652495
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. inhaled and topical steroids are allowed.
Description

Administration of immunosuppressants

Type de données

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0279021
administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
Description

Administration of long-acting immune-modifying drugs (e.g. infliximab)

Type de données

boolean

Alias
UMLS CUI [1]
C1134703
concurrently participating in another clinical study during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Hepatitis A NCT02124785

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Havrix therapy
Item
a male or female who received two doses of havrix in study hav-112 (208109/108) or hav-123 (208109/114), and received no further booster dose since then.
boolean
C0700881 (UMLS CUI [1])
compliance
Item
subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
boolean
C1321605 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
History of hepatitis
Item
history of hepatitis a disease since completion of the primary vaccination series in studies hav-112 (208109/108) or hav-123 (208109/114).
boolean
C1997459 (UMLS CUI [1])
Hepatitis A Vaccines
Item
administration of a hepatitis a vaccine at any time since completion of the primary vaccination series in studies hav-112 (208109/108) or hav-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
boolean
C0170300 (UMLS CUI [1])
Immunosuppressive or immunodeficient condition
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Hepatitis A immunoglobulin
Item
administration of hepatitis a immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
boolean
C3652495 (UMLS CUI [1])
Administration of immunosuppressants
Item
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. inhaled and topical steroids are allowed.
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
Administration of long-acting immune-modifying drugs (e.g. infliximab)
Item
administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
boolean
C1134703 (UMLS CUI [1])
Study Subject Participation Status
Item
concurrently participating in another clinical study during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial