Information:
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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
Link
https://clinicaltrials.gov/show/NCT02124785
Keywords
Versions (2)
- 11/17/15 11/17/15 -
- 11/17/15 11/17/15 - Julian Varghese
Uploaded on
November 17, 2015
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Hepatitis A NCT02124785
Eligibility Hepatitis A NCT02124785
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis A NCT02124785
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])