ID
38448
Description
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B
Keywords
Versions (1)
- 10/17/19 10/17/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 17, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)
Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up
Description
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Description
If no, specify reason
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
Description
If subject would not be willing to participate in a follow-up study, specify the reason
Data type
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [1,4]
- C2348235
Description
If reason is Adverse Event, or Serious Adverse Event, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [2,1]
- C0566251
- UMLS CUI [2,2]
- C1519255
- UMLS CUI [2,3]
- C2348235
Description
If other reason, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Has the code been broken?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0805701
Description
Did any elimination criteria become applicable during the study?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1706839
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0347984
Description
If any elimination criteria become applicabe during the study, please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1706839
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C2348235
Description
(a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
If subject dropped out, please mark the one most appropriate category for drop out
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0683312
Description
Please specify Adverse event number
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C2348235
Description
Please specify protocol violation.
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
If other reason for drop out, please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C2348235
Description
Date of last contact
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
If no, please give details within the Adverse Events section.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0805839
Description
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Description
I certify that I have reviewed the data in this case report form, the Non-Serious Adverse Events and Serious Adverse Event sections including any laboratory data (if appropriate) and that all information is complete and accurate.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Tracking Document Safety Follow-Up
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-3
- C1522577
- UMLS CUI-4
- C0036043
Description
Follow-up
Data type
integer
Alias
- UMLS CUI [1]
- C1522577
Description
(please PRINT name)
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Signature
Data type
text
Alias
- UMLS CUI [1]
- C1519316
Description
Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Tracking Document Safety Follow-Up
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
Description
Subject number
Data type
text
Alias
- UMLS CUI [1]
- C2348585
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
Did the subject experience any SAE(s) since the last contact?
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705415
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Description
Date of contact
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
Serious adverse event safety follow-up - Administrative
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C1320722
Description
Protocol
Data type
text
Alias
- UMLS CUI [1]
- C2348563
Description
Center
Data type
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Country
Data type
text
Alias
- UMLS CUI [1]
- C0454664
Description
GSK Receipt Date
Data type
date
Alias
- UMLS CUI [1]
- C2985846
Description
Subject Number
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
Serious adverse event safety follow-up
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
Description
Serious adverse event
Data type
integer
Alias
- UMLS CUI [1]
- C1519255
Description
Subject Demography - Initials - First name
Data type
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C2986440
- UMLS CUI [2,2]
- C1443235
Description
Subject Demography - Initials - Last name
Data type
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C2986440
- UMLS CUI [2,2]
- C1301584
Description
Subject Demography - Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0421451
Description
Subject Demography - Gender
Data type
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0079399
Description
(or signs and symptoms if not known)
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 [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826806
Description
(If ongoing please leave blank)
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826793
Description
SAE - Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
In your opinion, did the vaccine possibly contribute to the SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
- UMLS CUI [1,3]
- C0042210
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
SAE - If other possible contributors, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
(maximum)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
SAE - Action taken with respect to Study Vaccine
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C1519255
Description
SAE - Events after further vaccination
Data type
integer
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C1519255
Description
(mark all that apply).
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0243161
Description
Send autopsy report when available.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1320832
- UMLS CUI [1,3]
- C1519255
Description
If SAE required in-patient hospitalization, enter admission date
Data type
date
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1302393
- UMLS CUI [1,3]
- C1519255
Description
If SAE required in-patient hospitalization, enter discharge date
Data type
date
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C2361123
- UMLS CUI [1,3]
- C1519255
Description
If SAE required prolongation of existing hospitalization, enter discharge date
Data type
date
Alias
- UMLS CUI [1,1]
- C0745041
- UMLS CUI [1,2]
- C2361123
- UMLS CUI [1,3]
- C1519255
Description
If "medically important" event, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898777
- UMLS CUI [1,3]
- C2348235
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
- UMLS CUI [1,3]
- C0684224
Description
Was subject withdrawn due to this specific SAE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Description
Serious adverse event safety follow-up - Study vaccine information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C0304229
- UMLS CUI-5
- C0042210
Description
(specify mixed or separate)
Data type
text
Alias
- UMLS CUI [1]
- C0042210
Description
Vaccine Dose No
Data type
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0042210
Description
Vaccine Lot No
Data type
text
Alias
- UMLS CUI [1,1]
- C2826710
- UMLS CUI [1,2]
- C0042210
Description
Vaccine Route/ Site
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0013153
- UMLS CUI [2,3]
- C0042210
Description
Study Vaccine Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0011008
Description
Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-5
- C2347852
- UMLS CUI-6
- C0042210
- UMLS CUI-7
- C1519255
- UMLS CUI-8
- C0085978
Description
Drug/ vaccine
Data type
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0042210
Description
Medication dosage
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
Medication frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication start date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication end date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C3640977
- UMLS CUI-5
- C1880177
- UMLS CUI-6
- C1519255
- UMLS CUI-7
- C0262926
- UMLS CUI-8
- C1880177
- UMLS CUI-9
- C1519255
Description
Serious adverse event safety follow-up - Drug(s) used to treat this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C0013227
- UMLS CUI-5
- C0087111
- UMLS CUI-6
- C1519255
Description
Drug(s) used to treat this SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C1519255
Description
Drug for SAE - Dosage
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3174092
Description
Drug for SAE - Frequency
Data type
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C1519255
Description
Drug for SAE - Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1519255
Description
Drug for SAE - Start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1519255
Description
Drug for SAE - End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1519255
Description
Serious adverse event safety follow-up - Surgical treatment for this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C0543467
- UMLS CUI-5
- C1519255
Description
Serious adverse event safety follow-up - Description
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C0678257
- UMLS CUI-5
- C1519255
Description
Serious adverse event safety follow-up - Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C0947611
- UMLS CUI-5
- C1519255
Description
Serious adverse event safety follow-up - Investigator signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C0036043
- UMLS CUI-4
- C2346576
Description
Investigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Signature Clinical Development Manager
Data type
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
Description
Clinical Development Manager Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0681803
Description
Signature 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
text
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Similar models
Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up
C0600091 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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C2348235 (UMLS CUI [2,3])
C2348235 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,2])
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C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0683312 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
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C0036043 (UMLS CUI-4)
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C2986440 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
C0600091 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2986440 (UMLS CUI [2,1])
C1443235 (UMLS CUI [2,2])
C2986440 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
C0421451 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C2826806 (UMLS CUI [1,2])
C2826793 (UMLS CUI [1,2])
C1880177 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C1320832 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1302393 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3898777 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C0042210 (UMLS CUI-5)
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0013153 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2347852 (UMLS CUI-5)
C0042210 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C0085978 (UMLS CUI-8)
C0042210 (UMLS CUI [2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C3640977 (UMLS CUI-4)
C1880177 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0262926 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
C1519255 (UMLS CUI-9)
C0150312 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0087111 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1519255 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0678257 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1519255 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0947611 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1519255 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2346576 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])