ID
38174
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 (1)
- 24-09-19 24-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 september 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
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
Beschrijving
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beschrijving
(only one box must be checked)
Datatype
integer
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Side/ Site Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschrijving
Has the study vaccine been administered according to the Protocol?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Please check all items
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschrijving
If yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Beschrijving
Redness
Datatype
boolean
Alias
- UMLS CUI [1]
- C0332575
Beschrijving
Redness size Day 0
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschrijving
Redness size Day 1
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschrijving
Redness size Day 2
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschrijving
Redness size Day 3
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschrijving
Redness Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Redness is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschrijving
Swelling
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038999
Beschrijving
Swelling Size Day 0
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschrijving
Swelling Size Day 1
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschrijving
Swelling Size Day 2
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschrijving
Swelling Size Day 3
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschrijving
Swelling Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Swelling is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C0038999
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschrijving
Pain
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschrijving
Pain intensity Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
Beschrijving
Pain intensity Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
Beschrijving
Pain intensity Day 2
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
Beschrijving
Pain intensity Day 3
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
Beschrijving
Pain Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Pain is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschrijving
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beschrijving
If Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0159028
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Temperature Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beschrijving
Temperature Day 0
Datatype
float
Maateenheden
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature not taken Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C0437722
Beschrijving
Temperature Day 1
Datatype
float
Maateenheden
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature not taken Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C0437722
Beschrijving
Temperature Day 2
Datatype
float
Maateenheden
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature not taken Day 2
Datatype
integer
Alias
- UMLS CUI [1]
- C0437722
Beschrijving
Temperature Day 3
Datatype
float
Maateenheden
- °F
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature not taken Day 3
Datatype
integer
Alias
- UMLS CUI [1]
- C0437722
Beschrijving
Fever ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Fever is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C0015967
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschrijving
Fever - Causality?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0085978
Beschrijving
Irritability/ Fussiness
Datatype
boolean
Alias
- UMLS CUI [1]
- C0022107
Beschrijving
Irritability/ Fussiness intensity Day 0
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschrijving
Irritability/ Fussiness intensity Day 1
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschrijving
Irritability/ Fussiness intensity Day 2
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschrijving
Irritability/ Fussiness intensity Day 3
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
Beschrijving
Irritability/ Fussiness ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C0022107
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschrijving
Irritability/ Fussiness - Causality?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0085978
Beschrijving
Drowsiness
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013144
Beschrijving
Drowsiness intensity Day 0
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschrijving
Drowsiness intensity Day 1
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschrijving
Drowsiness intensity Day 2
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschrijving
Drowsiness intensity Day 3
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
Beschrijving
Drowsiness ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Drowsiness is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1457887
Beschrijving
Drowsiness - Causality?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0085978
Beschrijving
Loss of appetite
Datatype
boolean
Alias
- UMLS CUI [1]
- C1971624
Beschrijving
Loss of appetite intensity Day 0
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschrijving
Loss of appetite intensity Day 1
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschrijving
Loss of appetite intensity Day 2
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschrijving
Loss of appetite intensity Day 3
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
Beschrijving
Loss of appetite ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C3174772
Beschrijving
If Loss of appetite is ongoing, record date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1]
- C1971624
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beschrijving
Loss of appetite - Causality?
Datatype
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])