ID
35698
Beschrijving
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
Trefwoorden
Versies (3)
- 15-03-19 15-03-19 -
- 16-03-19 16-03-19 -
- 10-04-19 10-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 maart 2019
DOI
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Licentie
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;
Beschrijving
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Trade/ Generic Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Medical Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Code
Datatype
text
Alias
- UMLS CUI [1]
- C0805701
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Tick box if continuing at end of study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Beschrijving
Non-Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious Adverse Experiences Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Beschrijving
Non-Serious Adverse Experiences location
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
Beschrijving
Date Non-Serious Adverse Experience Started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
Datatype
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
Beschrijving
Date Non-Serious Adverse Experience Stopped
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
Non-Serious Adverse Experience Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1710066
Beschrijving
Non-Serious Adverse Experience Relationship
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439849
Beschrijving
Non-Serious Adverse Experience Outcome
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1519255
Beschrijving
SB Receipt Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985846
Beschrijving
Person Reporting SAE
Datatype
text
Alias
- UMLS CUI [1]
- C0008961
Beschrijving
AEGIS Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Beschrijving
Serious Adverse Experience
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Date and Time SAE Started
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Beschrijving
If ongoing please leave blank
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Experience Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beschrijving
Relationship to Study Vaccine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0439849
Beschrijving
Serious Adverse Experience Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Action taken with respect to Study Vaccine
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
If ’yes’, record details in the Concomitant Medication section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Mark all that apply.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beschrijving
If Serious Adverse Event is fatal, was autopsy performed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beschrijving
The SAE is probably associated with :
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
Beschrijving
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0184661
- UMLS CUI [1,4]
- C2348235
Beschrijving
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Beschrijving
SAE is associated with Another drug - Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C234823
Beschrijving
Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
If Experience Course is intermittent, record Number of episodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C0205267
- UMLS CUI [2]
- C4086638
Beschrijving
Was subject withdrawn due to this specific SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Experiences - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beschrijving
Test
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Date of Test
Datatype
date
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Test Value
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Normal Range
Datatype
text
Alias
- UMLS CUI [1]
- C0086715
Beschrijving
Serious Adverse Experiences - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beschrijving
Please provide a brief narrative description of the serious adverse experience, attaching extra pages eg, hospital discharge summary if necessary.
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
If applicable, was randomisation code broken at study site?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschrijving
Randomisation / Study Vaccine Number:
Datatype
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
Beschrijving
Confirming that the above data are accurate and complete.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Please PRINT name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
SB Medical Monitor Signature:
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Please PRINT name :
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
SB Medical Monitor Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
A drop out is a subject who did not come back for the concluding visit foreseen in the protocol.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0457454
Beschrijving
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
Datatype
text
Beschrijving
If SAE, please specify AEGIS No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0600091
- UMLS CUI [1,4]
- C2348235
Beschrijving
If Non-Serious Adverse Experience, please specify AE No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0600091
- UMLS CUI [1,4]
- C2348235
Beschrijving
If Protocol violation, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschrijving
If others, please specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschrijving
Date of last Contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
If no, please give details within the Adverse Experiences section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0805839
Beschrijving
I certify that I have reviewed the data in this case report form and that all information is complete and accurate.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date of Signature
Datatype
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])