ID
25019
Beschrijving
Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876
Link
https://clinicaltrials.gov/ct2/show/NCT00291876
Trefwoorden
Versies (3)
- 24-08-17 24-08-17 -
- 24-08-17 24-08-17 -
- 24-08-17 24-08-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 augustus 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Beschrijving
LOCAL SYMPTOMS
Beschrijving
Redness
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Redness size day 0
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Redness size day 1
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Redness size day 2
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Redness size day 3
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beschrijving
Ongoing after day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0549178
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size Swelling
Datatype
integer
Maateenheden
- dd/mm/yy
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size Swelling Day 0
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size Swelling Day 1
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size Swelling Day 2
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Size Swelling Day 3
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Ongoing after day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beschrijving
Pain (at injection site): 0 : Absent 1 : Painful on touch 2 : Painful when limb is moved 3 : Spontaneously painful
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3840282
- UMLS CUI [1,2]
- C2700396
Beschrijving
Pain intensity day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C3840282
Beschrijving
Pain intensity day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C3840282
Beschrijving
Pain intensity day 2
Datatype
integer
Alias
- UMLS CUI [1]
- C3840282
Beschrijving
Pain intensity day 3
Datatype
integer
Alias
- UMLS CUI [1]
- C3840282
Beschrijving
Ongoing after day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0030193
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
Beschrijving
Other Local Symptoms
Beschrijving
Description - please specify side(s) and site(s)
Datatype
text
Alias
- UMLS CUI [1]
- C0441987
- UMLS CUI [2]
- C1515974
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0522510
Beschrijving
Start date
Datatype
date
Maateenheden
- day month year
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Maateenheden
- day month year
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Ongoing
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschrijving
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Trade / Generic Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0013227
Beschrijving
Medical Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
pharmacotherapy ongoing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0549178
Beschrijving
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Beschrijving
Adverse Events General Symptoms
Datatype
text
Alias
- UMLS CUI [1]
- C1556354
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
body temperature site
Datatype
integer
Alias
- UMLS CUI [1]
- C0489453
Beschrijving
Fever Day 0
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever Day 1
Datatype
float
Maateenheden
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever Day 2
Datatype
float
Maateenheden
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Fever Day 3
Datatype
float
Maateenheden
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
symptom ongoing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C3174772
Beschrijving
date last symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Beschrijving
Fatigue
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
Fatigue Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
Fatigue Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
Fatigue Day 2
Datatype
integer
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
Fatigue Day 3
Datatype
integer
Alias
- UMLS CUI [1]
- C0015672
Beschrijving
Fatigue ongoing after day 3
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C3174772
Beschrijving
Date of last day of symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015672
- UMLS CUI [1,3]
- C2700396
Beschrijving
Headache
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
If Yes, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
Beschrijving
Headache on Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Headache on Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Headache on Day 2
Datatype
integer
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Headache on Day 3
Datatype
integer
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Headache ongoing after day 3
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Headache ongoing after day 3? If Yes, please specify
Datatype
date
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0011008
Beschrijving
Gastrointestinal symptoms
Datatype
boolean
Alias
- UMLS CUI [1]
- C0426576
Beschrijving
If Yes, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0522510
Beschrijving
Gastrointestinal symptoms on Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C0426576
Beschrijving
Gastrointestinal symptoms on Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C0426576
Beschrijving
Gastrointestinal symptoms on Day 2
Datatype
integer
Alias
- UMLS CUI [1]
- C0426576
Beschrijving
Gastrointestinal symptoms on Day 3
Datatype
integer
Alias
- UMLS CUI [1]
- C0426576
Beschrijving
Gastrointestinal symptoms ongoing after day 3
Datatype
boolean
Alias
- UMLS CUI [1]
- C0426576
Beschrijving
Gastrointestinal symptoms ongoing after day 3? If Yes, please specify
Datatype
date
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0011008
Beschrijving
visit date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
telephone number
Datatype
text
Alias
- UMLS CUI [1]
- C1515258
Beschrijving
Other General Symptoms
Alias
- UMLS CUI-1
- C1457887
Beschrijving
symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1457887
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
symptom Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
ongoing
Datatype
date
Alias
- UMLS CUI [1]
- C0549178
Similar models
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
C0600091 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C3174772 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3174772 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])