ID
38446
Beschrijving
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
Trefwoorden
Versies (2)
- 17-10-19 17-10-19 -
- 17-10-19 17-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschrijving
If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.
Datatype
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
Beschrijving
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschrijving
Trade / Generic Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0592502
Beschrijving
Concomitant vaccination Administration date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1533734
- UMLS CUI [1,4]
- C0011008
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
--> 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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C1533734
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Medication Trade / Generic Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0592502
Beschrijving
Medical Indication
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Medication total daily dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Beschrijving
Medication Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Medication stop date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Medication continuing at end of study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Beschrijving
Non-serious adverse events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
If yes, please complete the following table.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0687676
- UMLS CUI [2]
- C0877248
Beschrijving
Non-serious adverse events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-serious adverse event number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Non-serious adverse event Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Beschrijving
Non-serious adverse event site / Vaccine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0205145
- UMLS CUI [2]
- C0042210
Beschrijving
Non-serious adverse event start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1518404
Beschrijving
Non-serious advers event started during immediate post-vaccination period specified in protocol
Datatype
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
Beschrijving
Date non-serious adverse event stopped
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
Non-serious adverse event intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Beschrijving
In your opinion, did the vaccine possibly contribute to this AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1518404
Beschrijving
Non-serious adverse event outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious adverse event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious adverse event
Datatype
integer
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Subject Demography - Initials - First name
Datatype
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C2986440
- UMLS CUI [2,2]
- C1443235
Beschrijving
Subject Demography - Initials - Last name
Datatype
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C2986440
- UMLS CUI [2,2]
- C1301584
Beschrijving
Subject Demography - Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0421451
Beschrijving
Subject Demography - Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0079399
Beschrijving
(or signs and symptoms if not known)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Beschrijving
(Adverse event first symptoms)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826806
Beschrijving
(If ongoing please leave blank)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826793
Beschrijving
SAE - Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschrijving
In your opinion, did the vaccine possibly contribute to the SAE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
- UMLS CUI [1,3]
- C0042210
Beschrijving
(mark all that apply)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
Beschrijving
SAE - If other possible contributors, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
(maximum)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE - Action taken with respect to Study Vaccine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE - Events after further vaccination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C1519255
Beschrijving
(mark all that apply).
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0243161
Beschrijving
Send autopsy report when available
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1320832
- UMLS CUI [1,3]
- C1519255
Beschrijving
If SAE required in-patient hospitalization, enter admission date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1302393
- UMLS CUI [1,3]
- C1519255
Beschrijving
If SAE required in-patient hospitalization, enter discharge date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C2361123
- UMLS CUI [1,3]
- C1519255
Beschrijving
If SAE required prolongation of existing hospitalization, enter discharge date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0745041
- UMLS CUI [1,2]
- C2361123
- UMLS CUI [1,3]
- C1519255
Beschrijving
If
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898777
- UMLS CUI [1,3]
- C2348235
Beschrijving
Other events (not SAE) to be reported in the same way
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0684224
Beschrijving
Was subject withdrawn due to this specific SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious adverse event - Study vaccine information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C0042210
Beschrijving
(specify mixed or separate)
Datatype
text
Alias
- UMLS CUI [1]
- C0042210
Beschrijving
Vaccine Dose No
Datatype
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0042210
Beschrijving
Vaccine Lot No
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826710
- UMLS CUI [1,2]
- C0042210
Beschrijving
Vaccine Route/ Site
Datatype
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
Beschrijving
Study Vaccine Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0011008
Beschrijving
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
Beschrijving
Drug/ vaccine
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0042210
Beschrijving
Medication dosage
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Medication frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Medication Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication start date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Medication end date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
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
Beschrijving
Serious adverse event - Drug(s) used to treat this SAE
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C1519255
Beschrijving
Drug(s) used to treat this SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C1519255
Beschrijving
Drug for SAE - Dosage
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3174092
Beschrijving
Drug for SAE - Frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C1519255
Beschrijving
Drug for SAE - Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1519255
Beschrijving
Drug for SAE - Start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1519255
Beschrijving
Drug for SAE - End date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1519255
Beschrijving
Serious adverse event - Surgical treatment for this SAE
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C1519255
Beschrijving
SAE- Description
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C1519255
Beschrijving
SAE - Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator signature date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Signature Clinical Development Manager
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
Beschrijving
Clinical Development Manager Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0681803
Beschrijving
Clinical Development Manager
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
- UMLS CUI [1,3]
- C0011008
Beschrijving
AEGIS Number
Datatype
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])