ID
35931
Beschreibung
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
Stichworte
Versionen (2)
- 04.04.19 04.04.19 -
- 06.04.19 06.04.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. April 2019
DOI
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Lizenz
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
Beschreibung
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beschreibung
If No, please specify the most appropriate reason
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Beschreibung
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Beschreibung
If Adverse Event or Serious Adverse Event, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beschreibung
If other, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beschreibung
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
If Yes, specify total number of SAE's
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C2347804
- UMLS CUI [3]
- C2348563
Beschreibung
Total number of SAE's
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beschreibung
If Yes, complete the Pregnancy notification form.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
If Yes, record major reason for withdrawal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
Tick one box only
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beschreibung
Please complete and submit SAE report
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschreibung
Please complete Non-serious Adverse Event section
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0805701
Beschreibung
If protocol violation, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschreibung
If other reason, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beschreibung
Who made the decision?
Datentyp
text
Alias
- UMLS CUI [1]
- C0679006
Beschreibung
Date of last contact
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
If No, please give details in Adverse Events section.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschreibung
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-3
- C0558080
- UMLS CUI-4
- C0679823
- UMLS CUI-5
- C0392360
Beschreibung
Previous Subject Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Please document reason for non participation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beschreibung
Subject not eligible - Please specify criteria that are not fulfilled
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C3828770
- UMLS CUI [1,3]
- C2348235
Beschreibung
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1519255
Beschreibung
If other Reason for Subject not willing to participate, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschreibung
Date of contact
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Beschreibung
Diary Card - Local Symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschreibung
Local Symptoms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [2]
- C2700396
Beschreibung
Redness/ Swelling - Size in mm (Day 0)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beschreibung
Pain intensity (Day 0)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Redness/ Swelling - Size in mm (Day 1)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beschreibung
Pain intensity (Day 1)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Redness/ Swelling - Size in mm (Day 2)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beschreibung
Pain intensity (Day 2)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Redness/ Swelling - Size in mm (Day 3)
Datentyp
integer
Maßeinheiten
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beschreibung
Pain intensity (Day 3)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last day of symptom
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschreibung
Diary Card - Other local symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
- UMLS CUI-4
- C0205394
Beschreibung
Please specify side(s) and site(s)
Datentyp
text
Alias
- UMLS CUI [1]
- C0678257
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
Symptoms start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0808070
Beschreibung
Or check box if continuing
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0806020
Beschreibung
Check box if symptoms are continuing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschreibung
Diary Card - Medication
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0013227
Beschreibung
Trade/ Generic Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
- UMLS CUI [2]
- C0592502
Beschreibung
Reason for medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Total Daily Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Beschreibung
Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
Medication End date or check box if continuing
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0549178
Beschreibung
Check box if medication continuing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschreibung
Diary Card - General Symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0159028
Beschreibung
General Symptom
Datentyp
integer
Alias
- UMLS CUI [1]
- C0159028
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beschreibung
Record Temperature on Day 0, Day1, Day2, Day3
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0886414
Beschreibung
Record Intensity of Fatigue on Day0, Day1, Day2, Day3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0518690
Beschreibung
Headache intensity on Day0, Day1, Day2, Day3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0518690
Beschreibung
Gastrointestinal symptoms intensity on Day0, Day1, Day2, Day3
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0518690
Beschreibung
Symptoms ongoing after Day 3?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last Day of Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beschreibung
Diary Card - Other general Symptoms
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0029625
Beschreibung
Description - please give details below
Datentyp
text
Alias
- UMLS CUI [1]
- C0678257
Beschreibung
Symptom intensity
Datentyp
text
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
Symptom Start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0808070
Beschreibung
Symptoms End date or check box if continuing
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1457887
- UMLS CUI [2,2]
- C0549178
Beschreibung
Check box if symptoms continuing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Ähnliche Modelle
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])