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ID
35698
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
16. März 2019
DOI
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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;
Ähnliche Modelle
Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Trade Name
Item
Trade Name
text
C2360065 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
Prophylactic medication in anticipation of study vaccine reactions (P)
CL Item
Therapeutic (T)
CL Item
Chronic (C)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Tick box if continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,2])
CL Item
Continuing at end of study (1)
Non-Serious Adverse Experiences Description
Item
Non-Serious Adverse Experiences Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experiences location
integer
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
CL Item
Local (injection site) (1)
CL Item
General (noninjection site) (2)
CL Item
Left (3)
CL Item
Right (4)
Date Non-Serious Adverse Experience Started
Item
Date Non-Serious Adverse Experience Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
integer
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Code List
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
CL Item
Start Date during immediate post-vaccination period specified in protocol (1)
Date Non-Serious Adverse Experience Stopped
Item
Date Non-Serious Adverse Experience Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experience Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Non-Serious Adverse Experience Relationship
text
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
CL Item
Not related (NR)
CL Item
Unlikely (UL)
CL Item
Suspected (SU)
CL Item
Probable (PB)
Item
Non-Serious Adverse Experience Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
SB Receipt Date
Item
SB Receipt Date
date
C2985846 (UMLS CUI [1])
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Date and Time SAE Started
Item
Date and Time SAE Started
datetime
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
Date and Time SAE Stopped
Item
Date and Time SAE Stopped
datetime
C1519255 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
Serious Adverse Experience Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Relationship to Study Vaccine
text
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
CL Item
Not related (NR)
CL Item
Unlikely (UL)
CL Item
Suspected (reasonable possibility) (SU)
CL Item
Probable (PB)
Item
Serious Adverse Experience Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item
Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1])
CL Item
None (1)
CL Item
Vaccination course interrupted/ restarted (2)
CL Item
Vaccination course stopped (3)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious adverse experience.
integer
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious adverse experience.
CL Item
Fatal (1)
CL Item
Life threatening (2)
CL Item
Disabling/incapacitating (3)
CL Item
Results in hospitalisation (excluding elective surgery or routine clinical procedures that are not the result of an adverse experience) (4)
CL Item
Results in prolonged hospitalisation (5)
CL Item
Congenital abnormality in offspring (6)
CL Item
Associated with cancer (7)
CL Item
Associated with overdose (8)
CL Item
Any event which is regarded by the investigator as serious or which would suggest any significant hazard, contra-indication, side effect or precaution that may be associated with the use of the study vaccine should be reported as serious adverse experience. (9)
If Serious Adverse Event is fatal, was autopsy performed?
Item
If Serious Adverse Event is fatal, was autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item
The SAE is probably associated with :
integer
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,2])
CL Item
Protocol design or procedures (but not to study vaccine), please specify (1)
CL Item
Another condition (eg, condition under study, intercurrent illness), please specify (2)
CL Item
Another drug, please specify (3)
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
Item
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
Item
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
SAE is associated with Another drug - Specification
Item
SAE is associated with Another drug - Specification
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C234823 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C234823 (UMLS CUI [1,4])
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
CL Item
Intermittent (1)
CL Item
Constant (2)
If Experience Course is intermittent, record Number of episodes
Item
If Experience Course is intermittent, record Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C4086638 (UMLS CUI [2])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C4086638 (UMLS CUI [2])
Was subject withdrawn due to this specific SAE?
Item
Was subject withdrawn due to this specific SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Experiences - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Test
Item
Test
text
C0022885 (UMLS CUI [1])
Date of Test
Item
Date of Test
date
C2826247 (UMLS CUI [1])
Test Value
Item
Test Value
text
C0587081 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Item Group
Serious Adverse Experiences - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
If applicable, was randomisation code broken at study site?
Item
If applicable, was randomisation code broken at study site?
boolean
C0034656 (UMLS CUI [1])
Randomisation / Study Vaccine Number:
Item
Randomisation / Study Vaccine Number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0237753 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Please PRINT name
Item
Please PRINT name
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
SB Medical Monitor Signature:
Item
SB Medical Monitor Signature:
text
C2346576 (UMLS CUI [1])
Please PRINT name :
Item
Please PRINT name :
text
C2826892 (UMLS CUI [1])
SB Medical Monitor Signature Date
Item
SB Medical Monitor Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Has the subject dropped out of the study ?
Item
Has the subject dropped out of the study ?
boolean
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
Item
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
text
Code List
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
CL Item
Serious adverse experience (complete the Serious Adverse Experience form), please specify AEGIS No. (SAE)
CL Item
Non-serious adverse experience (complete the Non-Serious Adverse Experiences section), please specify AE No. (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to adverse experiences (CWS)
CL Item
Migration from study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Others, please specify (OTH)
If SAE, please specify AEGIS No.
Item
If SAE, please specify AEGIS No.
integer
C1519255 (UMLS CUI [1,1])
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])
If Non-Serious Adverse Experience, please specify AE No.
Item
If Non-Serious Adverse Experience, please specify AE No.
integer
C1518404 (UMLS CUI [1,1])
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])
If Protocol violation, please specify.
Item
If Protocol violation, please specify.
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
If others, please specify.
Item
If others, please specify.
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Date of last Contact
Item
Date of last Contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact ?
Item
Was the subject in good condition at date of last contact ?
boolean
C1142435 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])