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ID
25017
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
Similar models
GSK Hepatitis A Vaccine ADDITIONAL VACCINATION Diary Card NCT00291876
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Redness
Item
Redness, size
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])
Redness size day 0
Item
Redness size day 0
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])
Redness size day 1
Item
Redness size day 1
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])
Redness size day 2
Item
Redness size day 2
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])
Redness size day 3
Item
Redness size day 3
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 after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
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])
Size Swelling
Item
Size Swelling
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 0
Item
Size Swelling Day 0
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 1
Item
Size Swelling Day 1
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 2
Item
Size Swelling Day 2
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 3
Item
Size Swelling Day 3
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
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 intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
CL Item
HO (1)
CL Item
ER (2)
CL Item
MD (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0441987 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
C1515974 (UMLS CUI [2])
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek. medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing
Item
check box if continuing
boolean
C0549178 (UMLS CUI [1])
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Reason
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
pharmacotherapy
Item
check box if continuing
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])