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