ID
36110
Description
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Mots-clés
Versions (1)
- 15/04/2019 15/04/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
15 avril 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718
Long-Term Follow Up (Year 15, Additional Vaccination) - Check for Study Continuation; General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Solicited Adverse Events - Local and General Symptoms; Unsolicited Adverse Events
Description
Check for Study Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C0008976
Description
If yes, please complete the next pages. If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0332156
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1524062
Description
Please tick the ONE most appropriate reason and skip the following pages of this visit
Type de données
text
Alias
- UMLS CUI [1,1]
- C1522577
- UMLS CUI [1,2]
- C0332156
- UMLS CUI [1,3]
- C0392360
Description
If SAE, please specify SAE No
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
Type de données
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
If other reason, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Description
Please tick, who took the decision
Type de données
text
Alias
- UMLS CUI [1]
- C0679006
Description
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
Please tick appropriate box and give diagnosis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0521987
- UMLS CUI [2,1]
- C0037088
- UMLS CUI [2,2]
- C2347804
- UMLS CUI [2,3]
- C0332152
Description
Medical Condition
Alias
- UMLS CUI-1
- C0012634
Description
Medical Condition
Type de données
integer
Alias
- UMLS CUI [1]
- C0012634
Description
Diagnosis
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
Description
Status
Type de données
integer
Alias
- UMLS CUI [1]
- C0449438
Description
HCG Urine Pregnancy Test
Alias
- UMLS CUI-1
- C0430056
Description
Has a urine sample been taken ?
Type de données
integer
Alias
- UMLS CUI [1]
- C0430056
Description
Please complete only if different from visit date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Description
Result
Type de données
integer
Alias
- UMLS CUI [1]
- C1274040
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
fill in only if different from visit date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Pre-Vaccination temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0332152
Description
Temperature Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
(only one box must be ticked by vaccine)
Type de données
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Side/ Site Route
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Description
Has the study vaccine been administered according to the Protocol?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
If study vaccine has not been administered according to the Protocol, please tick all items that apply
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Please tick the ONE most appropriate category for non administration
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Description
If not administered because of SAE, please specify SAE No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0237753
Description
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0237753
Description
(e.g. consent withdrawal, protocol violation, …)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Description
Please tick who took the decision
Type de données
text
Alias
- UMLS CUI [1]
- C0679006
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Description
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Type de données
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
Description
Redness
Type de données
boolean
Alias
- UMLS CUI [1]
- C0332575
Description
Redness size Day 0
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Description
Redness size Day 1
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Description
Redness size Day 2
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Description
Redness size Day 3
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Description
Redness Ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C3174772
Description
If Redness is ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0332575
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Swelling
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038999
Description
Swelling Size Day 0
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Description
Swelling Size Day 1
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Description
Swelling Size Day 2
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Description
Swelling Size Day 3
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Description
Swelling Ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C3174772
Description
If Swelling is ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0038999
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030193
Description
Pain intensity Day 0
Type de données
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Pain intensity Day 1
Type de données
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Pain intensity Day 2
Type de données
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Pain intensity Day 3
Type de données
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Pain Ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C3174772
Description
If Pain is ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0030193
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Description
Has the subject experienced any of the following signs/symptoms during the solicited period?
Type de données
text
Alias
- UMLS CUI [1]
- C0037088
Description
Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Description
Temperature Day 0
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature not taken Day 0
Type de données
integer
Alias
- UMLS CUI [1]
- C0437722
Description
Temperature Day 1
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature not taken Day 1
Type de données
integer
Alias
- UMLS CUI [1]
- C0437722
Description
Temperature Day 2
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature not taken Day 2
Type de données
integer
Alias
- UMLS CUI [1]
- C0437722
Description
Temperature Day 3
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature not taken Day 3
Type de données
integer
Alias
- UMLS CUI [1]
- C0437722
Description
Fever ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C3174772
Description
If Fever is ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0015967
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Fever - Causality?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0085978
Description
Fatigue
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue intensity Day 0
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Description
Fatigue intensity Day 1
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Description
Fatigue intensity Day 2
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Description
Fatigue intensity Day 3
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Description
Fatigue ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3174772
Description
If Fatigue is ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0015672
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Fatigue - Causality?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0085978
Description
Headache
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
Headache intensity Day 0
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Description
Headache intensity Day 1
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Description
Headache intensity Day 2
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Description
Headache intensity Day 3
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Description
Headache ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C3174772
Description
If Headache is ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0018681
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Headache - Causality?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0085978
Description
Gastrointestinal symptoms
Type de données
boolean
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms intensity Day 0
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Description
Gastrointestinal symptoms intensity Day 1
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Description
Gastrointestinal symptoms intensity Day 2
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Description
Gastrointestinal symptoms intensity Day 3
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Description
Gastrointestinal Symptoms ongoing after Day 3?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C3174772
Description
If Gastrointestinal symptoms are ongoing after Day 3, record date of last Day of Symptoms
Type de données
date
Alias
- UMLS CUI [1]
- C0426576
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Description
Gastrointestinal Symptoms - Causality?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0085978
Description
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0687676
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0042196
- UMLS CUI [2,3]
- C0687676
Similar models
Long-Term Follow Up (Year 15, Additional Vaccination) - Check for Study Continuation; General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Solicited Adverse Events - Local and General Symptoms; Unsolicited Adverse Events
C0008976 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0332156 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0037088 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
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])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
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)
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 [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])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])