ID
36040
Beschreibung
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
Stichworte
Versionen (3)
- 15.03.19 15.03.19 -
- 16.03.19 16.03.19 -
- 10.04.19 10.04.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. April 2019
DOI
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Lizenz
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;
Beschreibung
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschreibung
Medication
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Trade/ Generic Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0592502
Beschreibung
Medical Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschreibung
Code
Datentyp
text
Alias
- UMLS CUI [1]
- C0805701
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Tick box if continuing at end of study
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Beschreibung
Non-Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Non-Serious Adverse Experiences Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Beschreibung
Non-Serious Adverse Experiences location
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0450429
Beschreibung
Date Non-Serious Adverse Experience Started
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschreibung
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
Datentyp
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
Beschreibung
Date Non-Serious Adverse Experience Stopped
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschreibung
Non-Serious Adverse Experience Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1710066
Beschreibung
Non-Serious Adverse Experience Relationship
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439849
Beschreibung
Non-Serious Adverse Experience Outcome
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1519255
Beschreibung
SB Receipt Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985846
Beschreibung
Person Reporting SAE
Datentyp
text
Alias
- UMLS CUI [1]
- C0008961
Beschreibung
AEGIS Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Beschreibung
Serious Adverse Experience
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Date and Time SAE Started
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Beschreibung
If ongoing please leave blank
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1519255
Beschreibung
Serious Adverse Experience Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beschreibung
Relationship to Study Vaccine
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0439849
Beschreibung
Serious Adverse Experience Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Action taken with respect to Study Vaccine
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
If ’yes’, record details in the Concomitant Medication section
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Mark all that apply.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beschreibung
If Serious Adverse Event is fatal, was autopsy performed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Beschreibung
The SAE is probably associated with :
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
Beschreibung
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0184661
- UMLS CUI [1,4]
- C2348235
Beschreibung
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C2348235
Beschreibung
SAE is associated with Another drug - Specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C2348235
Beschreibung
Experience Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
If Experience Course is intermittent, record Number of episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
- UMLS CUI [1,3]
- C0205267
- UMLS CUI [2]
- C4086638
Beschreibung
Was subject withdrawn due to this specific SAE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschreibung
Serious Adverse Experiences - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beschreibung
Test
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Date of Test
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Test Value
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Normal Range
Datentyp
text
Alias
- UMLS CUI [1]
- C0086715
Beschreibung
Serious Adverse Experiences - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0022885
Beschreibung
Please provide a brief narrative description of the serious adverse experience, attaching extra pages eg, hospital discharge summary if necessary.
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
If applicable, was randomisation code broken at study site?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschreibung
Randomisation / Study Vaccine Number:
Datentyp
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
Beschreibung
Confirming that the above data are accurate and complete.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Please PRINT name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
SB Medical Monitor Signature:
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Please PRINT name :
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
SB Medical Monitor Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
A drop out is a subject who did not come back for the concluding visit foreseen in the protocol.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0457454
Beschreibung
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1444662
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C2348568
Beschreibung
If SAE, please specify AEGIS No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0600091
- UMLS CUI [1,4]
- C2348235
Beschreibung
If Non-Serious Adverse Experience, please specify AE No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0600091
- UMLS CUI [1,4]
- C2348235
Beschreibung
If Protocol violation, please specify.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschreibung
If others, please specify.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschreibung
Date of last Contact
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
If no, please give details within the Adverse Experiences section
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0805839
Beschreibung
I certify that I have reviewed the data in this case report form and that all information is complete and accurate.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date of Signature
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;
C2347852 (UMLS CUI-2)
C0592502 (UMLS CUI [1,2])
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])
C2348235 (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])
C0392360 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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])