ID
35698
Beskrivning
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Nyckelord
Versioner (3)
- 2019-03-15 2019-03-15 -
- 2019-03-16 2019-03-16 -
- 2019-04-10 2019-04-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;
Beskrivning
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beskrivning
Medication
Alias
- UMLS CUI-1
- C0013227
Beskrivning
Trade/ Generic Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
Medical Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beskrivning
Code
Datatyp
text
Alias
- UMLS CUI [1]
- C0805701
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Tick box if continuing at end of study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Beskrivning
Non-Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Non-Serious Adverse Experiences Description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Beskrivning
Non-Serious Adverse Experiences location
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
Beskrivning
Date Non-Serious Adverse Experience Started
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beskrivning
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0687676
- UMLS CUI [1,5]
- C0205253
Beskrivning
Date Non-Serious Adverse Experience Stopped
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beskrivning
Non-Serious Adverse Experience Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1710066
Beskrivning
Non-Serious Adverse Experience Relationship
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439849
Beskrivning
Non-Serious Adverse Experience Outcome
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1519255
Beskrivning
SB Receipt Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2985846
Beskrivning
Person Reporting SAE
Datatyp
text
Alias
- UMLS CUI [1]
- C0008961
Beskrivning
AEGIS Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Beskrivning
Serious Adverse Experience
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Date and Time SAE Started
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Beskrivning
If ongoing please leave blank
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Experience Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beskrivning
Relationship to Study Vaccine
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0439849
Beskrivning
Serious Adverse Experience Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Action taken with respect to Study Vaccine
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
If ’yes’, record details in the Concomitant Medication section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Mark all that apply.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beskrivning
If Serious Adverse Event is fatal, was autopsy performed?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beskrivning
The SAE is probably associated with :
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
Beskrivning
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0184661
- UMLS CUI [1,4]
- C2348235
Beskrivning
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Beskrivning
SAE is associated with Another drug - Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C234823
Beskrivning
Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
If Experience Course is intermittent, record Number of episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C0205267
- UMLS CUI [2]
- C4086638
Beskrivning
Was subject withdrawn due to this specific SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Experiences - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beskrivning
Test
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Date of Test
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Value
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Normal Range
Datatyp
text
Alias
- UMLS CUI [1]
- C0086715
Beskrivning
Serious Adverse Experiences - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beskrivning
Please provide a brief narrative description of the serious adverse experience, attaching extra pages eg, hospital discharge summary if necessary.
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
If applicable, was randomisation code broken at study site?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034656
Beskrivning
Randomisation / Study Vaccine Number:
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0042210
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C0237753
Beskrivning
Confirming that the above data are accurate and complete.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Please PRINT name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
SB Medical Monitor Signature:
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Please PRINT name :
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
SB Medical Monitor Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
A drop out is a subject who did not come back for the concluding visit foreseen in the protocol.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0457454
Beskrivning
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
Datatyp
text
Beskrivning
If SAE, please specify AEGIS No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0600091
- UMLS CUI [1,4]
- C2348235
Beskrivning
If Non-Serious Adverse Experience, please specify AE No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0600091
- UMLS CUI [1,4]
- C2348235
Beskrivning
If Protocol violation, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beskrivning
If others, please specify.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beskrivning
Date of last Contact
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
If no, please give details within the Adverse Experiences section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0805839
Beskrivning
I certify that I have reviewed the data in this case report form and that all information is complete and accurate.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date of Signature
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;
C2347852 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
C0806020 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C234823 (UMLS CUI [1,4])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C4086638 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])