ID
25018
Description
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
Keywords
Versions (3)
- 8/24/17 8/24/17 -
- 8/24/17 8/24/17 -
- 8/24/17 8/24/17 -
Uploaded on
August 24, 2017
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Description
LOCAL SYMPTOMS
Description
Redness
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 0
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 1
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 2
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness size day 3
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Ongoing after day 3?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0549178
Description
Date of last day of symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling
Data type
integer
Measurement units
- dd/mm/yy
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 0
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 1
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 2
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Size Swelling Day 3
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Ongoing after day 3?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
Description
Date of last day of symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Pain (at injection site): 0 : Absent 1 : Painful on touch 2 : Painful when limb is moved 3 : Spontaneously painful
Data type
integer
Alias
- UMLS CUI [1,1]
- C3840282
- UMLS CUI [1,2]
- C2700396
Description
Pain intensity day 0
Data type
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Pain intensity day 1
Data type
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Pain intensity day 2
Data type
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Pain intensity day 3
Data type
integer
Alias
- UMLS CUI [1]
- C3840282
Description
Ongoing after day 3?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0549178
- UMLS CUI [1,2]
- C0030193
Description
Date of last day of symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
Description
Other Local Symptoms
Description
Description - please specify side(s) and site(s)
Data type
text
Alias
- UMLS CUI [1]
- C0441987
- UMLS CUI [2]
- C1515974
Description
Intensity
Data type
integer
Alias
- UMLS CUI [1]
- C0522510
Description
Start date
Data type
date
Measurement units
- day month year
Alias
- UMLS CUI [1]
- C0808070
Description
End date
Data type
date
Measurement units
- day month year
Alias
- UMLS CUI [1]
- C0806020
Description
Ongoing
Data type
boolean
Alias
- UMLS CUI [1]
- C0549178
Description
MEDICATION
Alias
- UMLS CUI-1
- C0013227
Description
Trade / Generic Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0013227
Description
Medical Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0013227
Description
Start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
pharmacotherapy ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013216
- UMLS CUI [1,2]
- C0549178
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
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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])