ID
38446
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 (2)
- 10/17/19 10/17/19 -
- 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)
Concomitant Vaccination; Medication; Non-serious adverse events; Serious adverse events
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [2,1]
- C2368628
- UMLS CUI [2,2]
- C2348563
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Trade / Generic Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0592502
Description
Concomitant vaccination Administration date
Data type
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1533734
- UMLS CUI [1,4]
- C0011008
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
--> Any immunosuppressants or other immune-modifying drugs or treatments and any antipyretics (and any drugs or treatments as specified in protocol) administered at ANY time during the period starting 30 days prior to the first dose of study vaccine(s) and ending one month (minimum 30 days) after the last dose of study vaccine(s) must be recorded with trade name and/or generic name of the medication, medical indication, total daily dose, route of administration, start and end dates of treatment. In addition, medications used in treating AEs should also be recorded. --> Any other concomitant medication administered prophylactically in anticipation of reaction to the vaccination must also be recorded with trade name and/or generic name of the medication, medical indication (check box if prophylactic), total daily dose, route of administration, start and end dates of treatment. If yes, please complete the following table.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C1533734
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Medication Trade / Generic Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0592502
Description
Medical Indication
Data type
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Medication total daily dose
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Description
Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Medication stop date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Medication continuing at end of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Description
Non-serious adverse events
Alias
- UMLS CUI-1
- C1518404
Description
If yes, please complete the following table.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0687676
- UMLS CUI [2]
- C0877248
Description
Non-serious adverse events
Alias
- UMLS CUI-1
- C1518404
Description
Non-serious adverse event number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Non-serious adverse event Description
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Description
Non-serious adverse event site / Vaccine
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0205145
- UMLS CUI [2]
- C0042210
Description
Non-serious adverse event start date
Data type
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1518404
Description
Non-serious advers event started during immediate post-vaccination period specified in protocol
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [3]
- C2348563
Description
Date non-serious adverse event stopped
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
Non-serious adverse event intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Description
In your opinion, did the vaccine possibly contribute to this AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1518404
Description
Non-serious adverse event outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Serious adverse event
Alias
- UMLS CUI-1
- C1519255
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
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 - Study vaccine information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- 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 - Concomitant medication/ Vaccination that could have contributed to this SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C2347852
- UMLS CUI-5
- C0042210
- UMLS CUI-6
- C1519255
- UMLS CUI-7
- 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 - Relevant intercurrent illness & medical history that could have contributed to this SAE
Alias
- UMLS CUI-1
- C3640977
- UMLS CUI-2
- C1880177
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C0262926
- UMLS CUI-5
- C1880177
- UMLS CUI-6
- C1519255
Description
Serious adverse event - Drug(s) used to treat this SAE
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- 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 - Surgical treatment for this SAE
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C1519255
Description
SAE- Description
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C1519255
Description
SAE - Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Description
Investigator signature
Alias
- UMLS CUI-1
- 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
Clinical Development Manager
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
Concomitant Vaccination; Medication; Non-serious adverse events; Serious adverse events
C2347852 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2368628 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C2347852 (UMLS CUI-2)
C2360065 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
C2347852 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
C0013227 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
C1518404 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2348563 (UMLS CUI [3])
C0806020 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
C1705586 (UMLS CUI [1,2])
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])
C0304229 (UMLS CUI-3)
C0042210 (UMLS CUI-4)
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])
C2347852 (UMLS CUI-3)
C0042210 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0085978 (UMLS CUI-7)
C0042210 (UMLS CUI [2])
C1880177 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0262926 (UMLS CUI-4)
C1880177 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0150312 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
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])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
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])