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ID
29296
Description
Visit 1 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B
Keywords
Versions (1)
- 3/16/18 3/16/18 -
Copyright Holder
GlaxoSmithKline (GSK)
Uploaded on
March 16, 2018
DOI
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License
Creative Commons BY-NC 3.0
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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915
Similar models
Visit 1: Day 0
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
General medical history/physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
C0031809 (UMLS CUI-3)
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
integer
C0262926 (UMLS CUI [1])
Code List
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (1)
CL Item
Yes, please check appropriate box(es) and give diagnosis (2)
CL Item
10 Cutaneous (1)
CL Item
5 Eyes (2)
CL Item
6 Ears-nose-throat (3)
CL Item
2 Cardiovascular (4)
CL Item
3 Respiratory (5)
CL Item
1 Gastrointestinal (6)
CL Item
7 Musculoskeletal (7)
CL Item
8 Neurological (8)
CL Item
12 Genitourinary (9)
CL Item
11 Haematology (10)
CL Item
4 Allergies (11)
CL Item
9 Endocrine (12)
CL Item
99 Other (specify) (13)
Item
Past or current?
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
CL Item
Past (1)
CL Item
Current (2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Temperature
Item
Pre-vaccination temperature
integer
C0039476 (UMLS CUI [1])
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Urine Sample
Item
Has a urine sample been taken?
boolean
C0200354 (UMLS CUI [1])
Item
Urine sample results (Pregnancy test – HCG)
integer
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item
Vaccine administration (only one box must be checked)
integer
C2368628 (UMLS CUI [1])
CL Item
Engerix™-B (20 mg) Thiomersal Free or Engerix™-B (10 mg) Preservative Free (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (*) (4)
Item
Side / site Route Non dominant Deltoid Deep I.M. (Please check appropriate box)
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Code List
Side / site Route Non dominant Deltoid Deep I.M. (Please check appropriate box)
CL Item
Left (1)
CL Item
Right (2)
Vaccine administration according to 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 you answered the previous question with 'No', please check all items: Site
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If you answered the previous question with 'No', please check all items: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Solicited adverse events - Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following local (at administration site) solicited signs/symptoms during the solicited period?
CL Item
Unknown (1)
CL Item
No (2)
CL Item
Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line. (3)
Redness
Item
Redness?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness size
Item
Size of local redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing redness
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Last symptoms of redness
Item
Date of last day of symptoms of redness:
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling
Item
Swelling?
boolean
C0038999 (UMLS CUI [1])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling size
Item
Size of local swelling
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing swelling
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Last Symptoms of swelling
Item
Date of last day of symptoms of swelling:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain
Item
Pain?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing pain
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Last symptoms of pain
Item
Date of last day of symptoms of pain:
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Solicited adverse events - General symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
CL Item
Unknown (1)
CL Item
No (2)
CL Item
Yes, please check a No/Yes box for each symptom. If Yes is checked, please fill in the complete line. (3)
Fever
Item
Fever?
boolean
C0015967 (UMLS CUI [1])
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Fever not taken
Item
Fever not taken?
boolean
C0015967 (UMLS CUI [1])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Ongoing fever
Item
Ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last fever symptoms
Item
Date of last fever symptoms
date
C0015967 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Fatigue
Item
Fatigue?
boolean
C0015672 (UMLS CUI [1])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity of fatigue
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing fatigue
Item
Ongoing after day 3?
boolean
C0015672 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last fatigue symptoms
Item
Date of last symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
Headache
Item
Headache?
boolean
C0018681 (UMLS CUI [1])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Headache intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing headache
Item
Ongoing after day 3?
boolean
C0018681 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last headache symptoms
Item
Date of last symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms?
boolean
C0426576 (UMLS CUI [1])
CL Item
Day 0 6 hours after vaccin. (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Gastrointestinal symptoms Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Ongoing Gastrointestinal symptoms
Item
Ongoing after day 3?
boolean
C0426576 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Gastrointestinal symptoms
Item
Date of last symptoms
date
C0011008 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,2])