Information:
Fel:
ID
38176
Beskrivning
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
Nyckelord
Versioner (2)
- 2019-04-08 2019-04-08 -
- 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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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718
Long-Term Follow Up (Year 12, Additional Vaccination) - Informed Consent; Demographics; Serious Adverse Event; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms
Similar models
Long-Term Follow Up (Year 12, Additional Vaccination) - Informed Consent; Demographics; Serious Adverse Event; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent date
Item
Informed Consent date:
date
C2985782 (UMLS CUI [1])
Centre number
Item
Centre number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
Has the subject had any serious adverse event since the last visit?
Item
Has the subject had any serious adverse event since the last visit?
boolean
C1519255 (UMLS CUI [1])
undefined item
Item
Specify number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of Blood sample been taken
Item
Date of Blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Has a urine sample been taken ?
integer
C0430056 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of urine sample been taken
Item
Date of urine sample been taken
date
C0430056 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Twinrix™ Adult (720/20) Vaccine (1)
CL Item
Twinrix™ Adult (720/20) Vaccine - Replacement vial (2)
CL Item
Twinrix™ Adult (720/20) Vaccine - Wrong vial number (3)
CL Item
Twinrix™ Adult (720/20) Vaccine not administered (4)
CL Item
Engerix™ (20 µg) Vaccine (5)
CL Item
Engerix™ (20 µg) Vaccine - Replacement vial (6)
CL Item
Engerix™ (20 µg) Vaccine - Wrong vial number (7)
CL Item
Engerix™ (20 µg) Vaccine not administered (8)
CL Item
Havrix™ (720 EL.U) Vaccine (9)
CL Item
Havrix™ (720 EL.U) Vaccine - Replacement vial (10)
CL Item
Havrix™ (720 EL.U) Vaccine - Wrong vial number (11)
CL Item
Havrix™ (720 EL.U)Vaccine not administered (12)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Item
Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
CL Item
Left Deltoid i.m. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please tick all items that apply
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Code List
If study vaccine has not been administered according to the Protocol, please tick all items that apply
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (3)
CL Item
Thigh (4)
CL Item
Buttock (5)
CL Item
i.m. (6)
CL Item
s.c. (7)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, …) (OTH)
If not administered because of SAE, please specify SAE No.
Item
If not administered because of SAE, please specify SAE No.
integer
C2368628 (UMLS CUI [1,1])
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])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
Item
If not administered because of Non-serious Adverse Event, please specify unsolicited or solicited AE No.
integer
C2368628 (UMLS CUI [1,1])
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])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
If other reason for non administration, please specify
Item
If other reason for non administration, please specify
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1])
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
C1519255 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (Y)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3? +
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
CL Item
Axillary (A)
CL Item
Oral (O)
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1])
CL Item
Not taken (1)
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1])
CL Item
Not taken (1)
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1])
CL Item
Not taken (1)
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1])
CL Item
Not taken (1)
Fever ongoing after Day 3?
Item
Fever ongoing after Day 3?
boolean
C0015967 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Fever is ongoing, record date of last Day of Symptoms
Item
If Fever is ongoing, record date of last Day of Symptoms
date
C0015967 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Fever - Causality?
Item
Fever - Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue intensity Day 0
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Fatigue intensity Day 1
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Fatigue intensity Day 2
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Fatigue intensity Day 3
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Fatigue ongoing after Day 3?
Item
Fatigue ongoing after Day 3?
boolean
C0015672 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Fatigue is ongoing, record date of last Day of Symptoms
Item
If Fatigue is ongoing, record date of last Day of Symptoms
date
C0015672 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Fatigue - Causality?
Item
Fatigue - Causality?
boolean
C0015672 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache intensity Day 0
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Headache intensity Day 1
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Headache intensity Day 2
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Headache intensity Day 3
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Headache ongoing after Day 3?
Item
Headache ongoing after Day 3?
boolean
C0018681 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Headache is ongoing, record date of last Day of Symptoms
Item
If Headache is ongoing, record date of last Day of Symptoms
date
C0018681 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Headache - Causality?
Item
Headache - Causality?
boolean
C0018681 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms intensity Day 0
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Gastrointestinal symptoms intensity Day 1
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Gastrointestinal symptoms intensity Day 2
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Item
Gastrointestinal symptoms intensity Day 3
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
Gastrointestinal Symptoms ongoing after Day 3?
Item
Gastrointestinal Symptoms ongoing after Day 3?
boolean
C0426576 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
Item
If Gastrointestinal symptoms are ongoing, record date of last Day of Symptoms
date
C0426576 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Gastrointestinal Symptoms - Causality?
Item
Gastrointestinal Symptoms - Causality?
boolean
C0426576 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])