ID
35727
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
Keywords
Versions (2)
- 3/18/19 3/18/19 -
- 3/18/19 3/18/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 18, 2019
DOI
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License
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)
Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
First Name, Family Name
Data type
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
If other Race, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Description
Would the subject be willing to participate in a follow-up study?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Description
If subject would not be willing to participate in a follow-up study, please specify the reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
- UMLS CUI [1,3]
- C0392360
Description
If Adverse Event or Serious Adverse Event, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Description
If other, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Description
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event (SAE)
Data type
integer
Alias
- UMLS CUI [1]
- C1519255
Description
First Name, Family Name
Data type
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C1997894
- UMLS CUI [2,2]
- C2986440
Description
Date of Birth (1)
Data type
date
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0421451
Description
Subject Demography - Gender (1)
Data type
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0079399
Description
Adverse Event - Diagnosis (2)
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Description
(Adverse event first symptoms)
Data type
datetime
Alias
- UMLS CUI [1]
- C2826806
Description
(If ongoing please leave blank)
Data type
datetime
Alias
- UMLS CUI [1]
- C2826793
Description
For GSK - Intensity of Adverse Event (5)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
For GSK - In your opinion, did the vaccine possibly contribute to the SAE? (6)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
- UMLS CUI [1,3]
- C0042196
Description
(mark all that apply)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
Description
(maximum)
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Action taken with respect to Study Vaccine (8)
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C0042210
Description
Events after further vaccination (9)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C1517331
Description
(mark all that apply)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0243161
- UMLS CUI [1,3]
- C2348235
Description
If yes, send autopsy report when available
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
If in-patient hospitalization required, enter Admission Date (10)
Data type
date
Alias
- UMLS CUI [1]
- C2826664
- UMLS CUI [2]
- C1302393
Description
If in-patient hospitalization required, enter Discharge Date (10)
Data type
date
Alias
- UMLS CUI [1]
- C2826664
- UMLS CUI [2]
- C2361123
Description
If prolongation of exisiting hospitalization, enter discharge date (10)
Data type
date
Alias
- UMLS CUI [1]
- C0745041
- UMLS CUI [2]
- C2361123
Description
Was subject withdrawn due to this specific SAE? (12)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
Other events (not SAE) to be reported in the same way
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0205394
Description
SAE - Study Vaccine Information (13)
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1533716
Description
(specify mixed or separate)
Data type
text
Alias
- UMLS CUI [1]
- C0042210
Description
Dose No
Data type
integer
Alias
- UMLS CUI [1]
- C1115464
Description
Lot No
Data type
integer
Alias
- UMLS CUI [1]
- C1115660
Description
Route / Site
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
SAE - Concomitant medication / vaccination that could have contributed to this SAE (14)
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1880177
- UMLS CUI-5
- C0042196
- UMLS CUI-6
- C2347852
- UMLS CUI-7
- C1519255
- UMLS CUI-8
- C1880177
Description
Drug / vaccine
Data type
text
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0042210
Description
Dosage
Data type
text
Alias
- UMLS CUI [1]
- C0178602
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15)
Alias
- UMLS CUI-1
- C0221423
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1880177
- UMLS CUI-4
- C0262926
- UMLS CUI-5
- C1519255
- UMLS CUI-6
- C1880177
Description
Drug(s) used to treat this SAE (16)
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C1519255
Description
Drug
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dosage
Data type
text
Alias
- UMLS CUI [1]
- C0178602
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Surgical treatment for this SAE (17)
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C1519255
Description
Description (18)
Alias
- UMLS CUI-1
- C0678257
Description
SAE - Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Description
Tracking Document
Alias
- UMLS CUI-1
- C3889409
Description
Subject number of previous study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Description
first name family name
Data type
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1517942
Description
Reason for Subject not willing to participate
Data type
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
Description
If other Reason for Subject not willing to participate, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Date of contact
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Description
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator Signature (1)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date (1)
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator Signature (2)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date (2)
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator Signature (3)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date (3)
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator Signature (4)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date (4)
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Clinical Development Manager - Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C0681803
- UMLS CUI [1,2]
- C1519316
Description
Clinical Development Manager - Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
- UMLS CUI [1,3]
- C0011008
Description
AEGIS Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
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C0262926 (UMLS CUI-4)
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C0150312 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
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C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
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C1517942 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1705415 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
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