ID
38445
Descripción
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
Palabras clave
Versiones (2)
- 17/10/19 17/10/19 -
- 17/10/19 17/10/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
17 de octubre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
- StudyEvent: ODM
Descripción
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Descripción
If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.
Tipo de datos
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
Descripción
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Descripción
Trade / Generic Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0592502
Descripción
Concomitant vaccination Administration date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1533734
- UMLS CUI [1,4]
- C0011008
Descripción
Medication
Alias
- UMLS CUI-1
- C0013227
Descripción
--> 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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C1533734
Descripción
Medication
Alias
- UMLS CUI-1
- C0013227
Descripción
Medication Trade / Generic Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0592502
Descripción
Medical Indication
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Descripción
Medication total daily dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
Descripción
Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Medication start date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
Medication stop date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
Medication continuing at end of study
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C2983670
Descripción
Non-serious adverse events
Alias
- UMLS CUI-1
- C1518404
Descripción
If yes, please complete the following table.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0687676
- UMLS CUI [2]
- C0877248
Descripción
Non-serious adverse events
Alias
- UMLS CUI-1
- C1518404
Descripción
Non-serious adverse event number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Descripción
Non-serious adverse event Description
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0678257
Descripción
Non-serious adverse event site / Vaccine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0205145
- UMLS CUI [2]
- C0042210
Descripción
Non-serious adverse event start date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2697888
- UMLS CUI [1,2]
- C1518404
Descripción
Non-serious advers event started during immediate post-vaccination period specified in protocol
Tipo de datos
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
Descripción
Date non-serious adverse event stopped
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Descripción
Non-serious adverse event intensity
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Descripción
In your opinion, did the vaccine possibly contribute to this AE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1518404
Descripción
Non-serious adverse event outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Descripción
Serious adverse event
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious adverse event
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1519255
Descripción
Subject Demography - Initials - First name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C2986440
- UMLS CUI [2,2]
- C1443235
Descripción
Subject Demography - Initials - Last name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2,1]
- C2986440
- UMLS CUI [2,2]
- C1301584
Descripción
Subject Demography - Date of Birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0421451
Descripción
Subject Demography - Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011298
- UMLS CUI [2]
- C0079399
Descripción
(or signs and symptoms if not known)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0011900
Descripción
(Adverse event first symptoms)
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826806
Descripción
(If ongoing please leave blank)
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826793
Descripción
SAE - Intensity
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Descripción
In your opinion, did the vaccine possibly contribute to the SAE
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
- UMLS CUI [1,3]
- C0042210
Descripción
(mark all that apply)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
Descripción
SAE - If other possible contributors, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
(maximum)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descripción
SAE - Action taken with respect to Study Vaccine
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C1519255
Descripción
SAE - Events after further vaccination
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C1519255
Descripción
(mark all that apply).
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0243161
Descripción
Send autopsy report when available
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1320832
- UMLS CUI [1,3]
- C1519255
Descripción
If SAE required in-patient hospitalization, enter admission date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1302393
- UMLS CUI [1,3]
- C1519255
Descripción
If SAE required in-patient hospitalization, enter discharge date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C2361123
- UMLS CUI [1,3]
- C1519255
Descripción
If SAE required prolongation of existing hospitalization, enter discharge date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0745041
- UMLS CUI [1,2]
- C2361123
- UMLS CUI [1,3]
- C1519255
Descripción
If
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898777
- UMLS CUI [1,3]
- C2348235
Descripción
Other events (not SAE) to be reported in the same way
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0684224
Descripción
Was subject withdrawn due to this specific SAE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Descripción
Serious adverse event - Study vaccine information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C0042210
Descripción
(specify mixed or separate)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0042210
Descripción
Vaccine Dose No
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0042210
Descripción
Vaccine Lot No
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826710
- UMLS CUI [1,2]
- C0042210
Descripción
Vaccine Route/ Site
Tipo de datos
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
Descripción
Study Vaccine Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0011008
Descripción
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
Descripción
Drug/ vaccine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0042210
Descripción
Medication dosage
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3174092
Descripción
Medication frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Medication start date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826734
Descripción
Medication end date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826744
Descripción
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
Descripción
Serious adverse event - Drug(s) used to treat this SAE
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C1519255
Descripción
Drug(s) used to treat this SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C1519255
Descripción
Drug for SAE - Dosage
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3174092
Descripción
Drug for SAE - Frequency
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C1519255
Descripción
Drug for SAE - Route
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1519255
Descripción
Drug for SAE - Start date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1519255
Descripción
Drug for SAE - End date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1519255
Descripción
Serious adverse event - Surgical treatment for this SAE
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C1519255
Descripción
SAE- Description
Alias
- UMLS CUI-1
- C0678257
- UMLS CUI-2
- C1519255
Descripción
SAE - Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Descripción
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Descripción
Investigator signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator signature date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Signature Clinical Development Manager
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
Descripción
Clinical Development Manager Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0681803
Descripción
Clinical Development Manager
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0681803
- UMLS CUI [1,3]
- C0011008
Descripción
AEGIS Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Similar models
Concomitant Vaccination; Medication
- StudyEvent: ODM
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])