ID
38174
Beschreibung
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
Stichworte
Versionen (1)
- 24.09.19 24.09.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. September 2019
DOI
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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
Beschreibung
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beschreibung
(only one box must be checked)
Datentyp
integer
Alias
- UMLS CUI [1]
- C2368628
Beschreibung
Side/ Site Route
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschreibung
Has the study vaccine been administered according to the Protocol?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschreibung
Please check all items
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschreibung
If yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Beschreibung
Redness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0332575
Beschreibung
Redness size Day 0
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness size Day 1
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness size Day 2
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness size Day 3
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
Redness Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Redness is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Swelling
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038999
Beschreibung
Swelling Size Day 0
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size Day 1
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size Day 2
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Size Day 3
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Swelling Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Swelling is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0038999
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Pain
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschreibung
Pain intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Pain Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Pain is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beschreibung
If Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0159028
Beschreibung
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)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschreibung
Temperature Route
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beschreibung
Temperature Day 0
Datentyp
float
Maßeinheiten
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 0
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Temperature Day 1
Datentyp
float
Maßeinheiten
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 1
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Temperature Day 2
Datentyp
float
Maßeinheiten
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 2
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Temperature Day 3
Datentyp
float
Maßeinheiten
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature not taken Day 3
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437722
Beschreibung
Fever ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Fever is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0015967
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Fever - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0085978
Beschreibung
Irritability/ Fussiness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0022107
Beschreibung
Irritability/ Fussiness intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschreibung
Irritability/ Fussiness intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschreibung
Irritability/ Fussiness intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschreibung
Irritability/ Fussiness intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschreibung
Irritability/ Fussiness ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C0022107
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Irritability/ Fussiness - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0085978
Beschreibung
Drowsiness
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013144
Beschreibung
Drowsiness intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschreibung
Drowsiness intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschreibung
Drowsiness intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschreibung
Drowsiness intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschreibung
Drowsiness ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Drowsiness is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1457887
Beschreibung
Drowsiness - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0085978
Beschreibung
Loss of appetite
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1971624
Beschreibung
Loss of appetite intensity Day 0
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschreibung
Loss of appetite intensity Day 1
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschreibung
Loss of appetite intensity Day 2
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschreibung
Loss of appetite intensity Day 3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschreibung
Loss of appetite ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C3174772
Beschreibung
If Loss of appetite is ongoing, record date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C1971624
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschreibung
Loss of appetite - Causality?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0085978
Ähnliche Modelle
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])