ID
35931
Beskrivning
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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)
- 2019-04-04 2019-04-04 -
- 2019-04-06 2019-04-06 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 april 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Study Conclusion - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card
Beskrivning
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beskrivning
If No, please specify the most appropriate reason
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Beskrivning
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Beskrivning
If Adverse Event or Serious Adverse Event, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beskrivning
If other, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beskrivning
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
If Yes, specify total number of SAE's
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C2347804
- UMLS CUI [3]
- C2348563
Beskrivning
Total number of SAE's
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beskrivning
If Yes, complete the Pregnancy notification form.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
If Yes, record major reason for withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
Tick one box only
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beskrivning
Please complete and submit SAE report
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
Please complete Non-serious Adverse Event section
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0805701
Beskrivning
If protocol violation, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beskrivning
If other reason, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beskrivning
Who made the decision?
Datatyp
text
Alias
- UMLS CUI [1]
- C0679006
Beskrivning
Date of last contact
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
If No, please give details in Adverse Events section.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beskrivning
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-3
- C0558080
- UMLS CUI-4
- C0679823
- UMLS CUI-5
- C0392360
Beskrivning
Previous Subject Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Please document reason for non participation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beskrivning
Subject not eligible - Please specify criteria that are not fulfilled
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C3828770
- UMLS CUI [1,3]
- C2348235
Beskrivning
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1519255
Beskrivning
If other Reason for Subject not willing to participate, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Date of contact
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Beskrivning
Diary Card - Local Symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beskrivning
Local Symptoms
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [2]
- C2700396
Beskrivning
Redness/ Swelling - Size in mm (Day 0)
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 0)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Redness/ Swelling - Size in mm (Day 1)
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 1)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Redness/ Swelling - Size in mm (Day 2)
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 2)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Redness/ Swelling - Size in mm (Day 3)
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 3)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last day of symptom
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beskrivning
Diary Card - Other local symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
- UMLS CUI-4
- C0205394
Beskrivning
Please specify side(s) and site(s)
Datatyp
text
Alias
- UMLS CUI [1]
- C0678257
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
Symptoms start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0808070
Beskrivning
Or check box if continuing
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0806020
Beskrivning
Check box if symptoms are continuing
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beskrivning
Diary Card - Medication
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0013227
Beskrivning
Trade/ Generic Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
- UMLS CUI [2]
- C0592502
Beskrivning
Reason for medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Total Daily Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Beskrivning
Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Medication End date or check box if continuing
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0549178
Beskrivning
Check box if medication continuing
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beskrivning
Diary Card - General Symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0159028
Beskrivning
General Symptom
Datatyp
integer
Alias
- UMLS CUI [1]
- C0159028
Beskrivning
Please record the temperature every day in the evening. If temperature has been taken more than once a day, please report the highest value for the day.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beskrivning
Record Temperature on Day 0, Day1, Day2, Day3
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0886414
Beskrivning
Record Intensity of Fatigue on Day0, Day1, Day2, Day3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beskrivning
Headache intensity on Day0, Day1, Day2, Day3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beskrivning
Gastrointestinal symptoms intensity on Day0, Day1, Day2, Day3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Beskrivning
Symptoms ongoing after Day 3?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last Day of Symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beskrivning
Diary Card - Other general Symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0029625
Beskrivning
Description - please give details below
Datatyp
text
Alias
- UMLS CUI [1]
- C0678257
Beskrivning
Symptom intensity
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
Beskrivning
Symptom Start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0808070
Beskrivning
Symptoms End date or check box if continuing
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1457887
- UMLS CUI [2,2]
- C0549178
Beskrivning
Check box if symptoms continuing
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Similar models
Study Conclusion - Follow-Up Studies; Study Conclusion; Tracking Document; Diary Card
C0600091 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347804 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
C0449788 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C0558080 (UMLS CUI-3)
C0679823 (UMLS CUI-4)
C0392360 (UMLS CUI-5)
C2242969 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C3828770 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1705415 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C0592502 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0159028 (UMLS CUI-2)
C0449444 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0029625 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])