ID
33880
Description
Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B
Keywords
Versions (1)
- 1/5/19 1/5/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 5, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B
Eligibility Checklist
- StudyEvent: ODM
Description
Exclusion Criteria for Enrollment
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C1516879
Description
Pharmaceutical Preparations, Vaccines
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0042210
Description
Administration of vaccine, Planned
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1301732
Description
Hepatitis B vaccination, Previous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0474232
- UMLS CUI [1,2]
- C0205156
Description
Hepatitis B vaccination, Previous, Absent response to treatment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0474232
- UMLS CUI [1,2]
- C0205156
- UMLS CUI [1,3]
- C0438286
Description
Hepatitis B, Exposure to
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019163
- UMLS CUI [1,2]
- C0332157
Description
Hepatitis B, Medical History
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019163
- UMLS CUI [1,2]
- C0262926
Description
Immunosuppression, Immunologic Deficiency Syndromes, HIV
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4048329
- UMLS CUI [1,2]
- C0021051
- UMLS CUI [1,3]
- C0019682
Description
Immunodeficiency congenital, Immunologic Deficiency Syndromes, Hereditary, Family history
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0853602
- UMLS CUI [1,2]
- C0021051
- UMLS CUI [1,3]
- C0439660
- UMLS CUI [1,4]
- C0241889
Description
Hypersensitivity, Medical History
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0262926
Description
Acute Disease, Enrollment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001314
- UMLS CUI [1,2]
- C1516879
Description
Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019209
- UMLS CUI [1,2]
- C0235299
- UMLS CUI [1,3]
- C0238571
Description
Immunoglobulins, Blood product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Description
Pregnancy, Breast Feeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C0008976
Description
Hepatitis B positive
Data type
boolean
Alias
- UMLS CUI [1]
- C0856706
Description
Pharmaceutical Preparations, Vaccines
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0042210
Description
Vaccines, Administration procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1533734
Description
Immunoglobulins, Blood product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Description
Pregnancy, Planned
Data type
boolean
Alias
- UMLS CUI [1]
- C0032992
Description
Contraindications to vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0522473
Description
Hepatomegaly, Right upper quadrant pain, Right upper quadrant abdominal tenderness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019209
- UMLS CUI [1,2]
- C0235299
- UMLS CUI [1,3]
- C0238571
Description
Anaphylaxis, Vaccination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0002792
- UMLS CUI [1,2]
- C0042196
Description
Pregnancy
Data type
boolean
Alias
- UMLS CUI [1]
- C0032961
Description
Acute Disease, Vaccination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001314
- UMLS CUI [1,2]
- C0042196
Similar models
Eligibility Checklist
- StudyEvent: ODM
C0001779 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,2])
C1516879 (UMLS CUI-2)
C0042210 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
C0438286 (UMLS CUI [1,3])
C0332157 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,3])
C0241889 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,2])
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
C0456388 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0042210 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
C0522473 (UMLS CUI-2)
C0235299 (UMLS CUI [1,2])
C0238571 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])