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