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