ID
33929
Beschrijving
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
Trefwoorden
Versies (1)
- 08-01-19 08-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 januari 2019
DOI
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Licentie
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
Serious Adverse Events
- StudyEvent: ODM
Beschrijving
Subject Demography
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1704791
Beschrijving
Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event, Diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Beschrijving
Serious Adverse Event, Start Date, Start Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Beschrijving
Serious Adverse Event, Symptom intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beschrijving
Serious Adverse Event, Relationship, Vaccines
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0042210
Beschrijving
Serious Adverse Event, Adverse Event Outcome
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Event, Action taken with study
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C0042210
Beschrijving
Serious Adverse Event, Vaccination, Continuous, Event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0549178
- UMLS CUI [1,4]
- C0441471
Beschrijving
Serious Adverse Event, Criteria
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0243161
Beschrijving
Event, Other
Datatype
text
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0205394
Beschrijving
Serious Adverse Event, Etiology aspects
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0015127
Beschrijving
Serious Adverse Event, Withdraw
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beschrijving
Study vaccine information
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1533716
Beschrijving
Vaccines, Experimental
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0304229
Beschrijving
Vaccines, Dose, Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1115464
Beschrijving
Vaccines, Lot Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1115660
Beschrijving
Vaccines, Drug Administration Routes, Anatomical Site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C1515974
Beschrijving
Vaccines, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0011008
Beschrijving
Concomitant medication / vaccination that could have contributed to this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschrijving
Serious Adverse Event, Concomitant Agent
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
Beschrijving
Serious Adverse Event, Concomitant Agent, Medication dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C3174092
Beschrijving
Serious Adverse Event, Concomitant Agent, Frequencies
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Beschrijving
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Beschrijving
Serious Adverse Event, Concomitant Agent, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Concomitant Agent, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0806020
Beschrijving
Relevant intercurrent illness & medical history hat could have contributed to this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
Beschrijving
Drug(s) used to treat this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013227
Beschrijving
Serious Adverse Event, Pharmaceutical Preparations
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
Beschrijving
Serious Adverse Event, Pharmaceutical Preparations, Dosage
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0178602
Beschrijving
Serious Adverse Event, Pharmaceutical Preparations, Frequencies
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0439603
Beschrijving
Serious Adverse Event, Pharmaceutical Preparations, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0013153
Beschrijving
Serious Adverse Event, Pharmaceutical Preparations, Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0808070
Beschrijving
Serious Adverse Event, Pharmaceutical Preparations, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0806020
Beschrijving
Surgical treatment for this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0543467
Beschrijving
Description
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0678257
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Serious Adverse Events
- StudyEvent: ODM
C1704791 (UMLS CUI-2)
C0011900 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C1115464 (UMLS CUI [1,2])
C1115660 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0012634 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0543467 (UMLS CUI-2)
C0543467 (UMLS CUI [1,2])
C0678257 (UMLS CUI-2)
C0678257 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])