ID
38174
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 (1)
- 2019-09-24 2019-09-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 september 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)
Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Events - Local and General Symptoms
Beskrivning
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beskrivning
(only one box must be checked)
Datatyp
integer
Alias
- UMLS CUI [1]
- C2368628
Beskrivning
Side/ Site Route
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beskrivning
Has the study vaccine been administered according to the Protocol?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beskrivning
Please check all items
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beskrivning
If yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Beskrivning
Redness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0332575
Beskrivning
Redness size Day 0
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beskrivning
Redness size Day 1
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beskrivning
Redness size Day 2
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beskrivning
Redness size Day 3
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beskrivning
Redness Ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Redness is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Swelling
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038999
Beskrivning
Swelling Size Day 0
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beskrivning
Swelling Size Day 1
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beskrivning
Swelling Size Day 2
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beskrivning
Swelling Size Day 3
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beskrivning
Swelling Ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Swelling is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C0038999
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Pain
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
Pain intensity Day 0
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Pain intensity Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Pain intensity Day 2
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Pain intensity Day 3
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Pain Ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Pain is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beskrivning
If Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0159028
Beskrivning
Rectal > 100.4°F (38°C) Axillary > 99.5°F (37.5°C) Tympanic oral > 99.5°F (37.5°C) Tympanic rectal > 100.4°F (38°C)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature Route
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beskrivning
Temperature Day 0
Datatyp
float
Måttenheter
- °F
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Temperature not taken Day 0
Datatyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beskrivning
Temperature Day 1
Datatyp
float
Måttenheter
- °F
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Temperature not taken Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beskrivning
Temperature Day 2
Datatyp
float
Måttenheter
- °F
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Temperature not taken Day 2
Datatyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beskrivning
Temperature Day 3
Datatyp
float
Måttenheter
- °F
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Temperature not taken Day 3
Datatyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beskrivning
Fever ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Fever is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C0015967
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Fever - Causality?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0085978
Beskrivning
Irritability/ Fussiness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0022107
Beskrivning
Irritability/ Fussiness intensity Day 0
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beskrivning
Irritability/ Fussiness intensity Day 1
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beskrivning
Irritability/ Fussiness intensity Day 2
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beskrivning
Irritability/ Fussiness intensity Day 3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beskrivning
Irritability/ Fussiness ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C0022107
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Irritability/ Fussiness - Causality?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0085978
Beskrivning
Drowsiness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013144
Beskrivning
Drowsiness intensity Day 0
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beskrivning
Drowsiness intensity Day 1
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beskrivning
Drowsiness intensity Day 2
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beskrivning
Drowsiness intensity Day 3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beskrivning
Drowsiness ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Drowsiness is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1457887
Beskrivning
Drowsiness - Causality?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0085978
Beskrivning
Loss of appetite
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1971624
Beskrivning
Loss of appetite intensity Day 0
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beskrivning
Loss of appetite intensity Day 1
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beskrivning
Loss of appetite intensity Day 2
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beskrivning
Loss of appetite intensity Day 3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beskrivning
Loss of appetite ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C3174772
Beskrivning
If Loss of appetite is ongoing, record date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C1971624
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Loss of appetite - Causality?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0085978
Similar models
Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Events - Local and General Symptoms
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0085978 (UMLS CUI [1,2])