ID

24631

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 (1)
  1. 8/10/17 8/10/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 10, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine SERIOUS ADVERSE EVENT NCT00291876

English

GSK Hepatitis A Vaccine SERIOUS ADVERSE EVENT NCT00291876

1 forms  
Study administration
Description

Study administration

Center
Description

Center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Country
Description

Country

Data type

text

Alias
UMLS CUI [1]
C0454664
GS Receipt Date
Description

Receipt Date

Data type

date

Alias
UMLS CUI [1]
C2985846
Subject Number
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
SERIOUS ADVERSE EVENT (SAE)
Description

SERIOUS ADVERSE EVENT (SAE)

SERIOUS ADVERSE EVENT (SAE)
Description

Serious adverse event

Data type

text

Alias
UMLS CUI [1]
C1519255
Subject Demography
Description

Subject Demography

Initials
Description

Initials

Data type

text

Measurement units
  • _ _ First Name / _ _ Family Name
Alias
UMLS CUI [1]
C2986440
_ _ First Name / _ _ Family Name
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Adverse Event Diagnosis (or signs and symptoms if not known)
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
For GSK
Description

For GSK

Date and time started:
Description

(Adverse event first symptoms)

Data type

datetime

Alias
UMLS CUI [1]
C2697888
Date and time stopped:
Description

(If ongoing please leave blank)

Data type

datetime

Alias
UMLS CUI [1]
C2697886
Intensity:
Description

(maximum)

Data type

integer

Alias
UMLS CUI [1]
C1710066
In your opinion, did the vaccine possibly contribute to the SAE:
Description

vaccine causing sae

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0042196
Outcome:
Description

(maximum)

Data type

integer

Alias
UMLS CUI [1]
C1705586
Other possible contributors:
Description

Other possible contributors:

Medical history
Description

(record in section 15)

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0262926
Other medication
Description

(record in section 14)

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0013227
Protocol required procedure
Description

Protocol required procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0184661
Other procedure
Description

Other procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0393107
Lack of efficacy
Description

Lack of efficacy

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0235828
Erroneous administration
Description

Erroneous administration

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0549489
Other, specify:
Description

Other sae contribution

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
Other, specify:
Description

Other sae contribution

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
Action taken with respect to Study Vaccine
Description

action taken

Data type

integer

Alias
UMLS CUI [1]
C2826626
Events after further vaccination
Description

further adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0877248
Other events (not SAE) to be reported in the same way: Cancer
Description

Other events

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2826307
Was subject withdrawn due to this specific SAE?
Description

withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Specify criteria for considering this as a Serious Adverse Event.
Description

Specify criteria for considering this as a Serious Adverse Event.

Result in death --> Autopsy?
Description

Send autopsy report when available

Data type

boolean

Alias
UMLS CUI [1]
C1320832
Life threatening
Description

adverse event life threatening

Data type

boolean

Alias
UMLS CUI [1]
C1517874
Result in persistent or significant disability/incapacity
Description

adverse event disability

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0231170
Requires in-patient hospitalization.
Description

Adverse Event associated with Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C2826664
Admission date:
Description

admission date

Data type

date

Alias
UMLS CUI [1,1]
C1302393
UMLS CUI [1,2]
C1519255
Discharge date
Description

Discharge date

Data type

date

Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C1519255
Prolongation of existing hospitalization
Description

Prolongation of existing hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0745041
Discharge date
Description

Discharge date

Data type

date

Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C1519255
Congenital anomaly / birth defect in the offspring of a study subject.
Description

Congenital anomaly

Data type

boolean

Alias
UMLS CUI [1]
C2826727
“Medically important” event specify:
Description

other event

Data type

boolean

Alias
UMLS CUI [1]
C1710056
“Medically important” event specify:
Description

other event

Data type

text

Alias
UMLS CUI [1]
C1710056
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Similar models

GSK Hepatitis A Vaccine SERIOUS ADVERSE EVENT NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Receipt Date
Item
GS Receipt Date
date
C2985846 (UMLS CUI [1])
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
SERIOUS ADVERSE EVENT (SAE)
Item
SERIOUS ADVERSE EVENT (SAE)
text
C1519255 (UMLS CUI [1])
Serious adverse event
Code List
SERIOUS ADVERSE EVENT (SAE)
CL Item
(1) Initial report ((1) Initial report)
CL Item
(2) Additional info ((2) Additional info)
CL Item
(3) Additional info ((3) Additional info)
CL Item
(4) Additional info ((4) Additional info)
Item Group
Subject Demography
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Adverse Event
Item
Adverse Event Diagnosis (or signs and symptoms if not known)
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item Group
For GSK
adverse event start date
Item
Date and time started:
datetime
C2697888 (UMLS CUI [1])
adverse event end date
Item
Date and time stopped:
datetime
C2697886 (UMLS CUI [1])
Item
Intensity:
integer
C1710066 (UMLS CUI [1])
adverse event intensitiy
Code List
Intensity:
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
vaccine causing sae
Item
In your opinion, did the vaccine possibly contribute to the SAE:
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Item
Outcome:
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome:
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
Item Group
Other possible contributors:
Medical history
Item
Medical history
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Other medication
Item
Other medication
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Protocol required procedure
Item
Protocol required procedure
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Other procedure
Item
Other procedure
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0393107 (UMLS CUI [1,3])
Lack of efficacy
Item
Lack of efficacy
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0235828 (UMLS CUI [1,3])
Erroneous administration
Item
Erroneous administration
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0549489 (UMLS CUI [1,3])
Other sae contribution
Item
Other, specify:
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other sae contribution
Item
Other, specify:
text
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Item
Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1])
action taken
Code List
Action taken with respect to Study Vaccine
CL Item
None (1)
CL Item
Vaccination course postponed (2)
CL Item
Vaccination course stopped (3)
Item
Events after further vaccination
integer
C0035020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
further adverse event
Code List
Events after further vaccination
CL Item
Event reappeared (1)
CL Item
Event did not reappear (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Other events
Item
Other events (not SAE) to be reported in the same way: Cancer
boolean
C0006826 (UMLS CUI [1,1])
C2826307 (UMLS CUI [1,2])
withdrawal
Item
Was subject withdrawn due to this specific SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Specify criteria for considering this as a Serious Adverse Event.
adverse event results in death
Item
Result in death --> Autopsy?
boolean
C1320832 (UMLS CUI [1])
adverse event life threatening
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
adverse event disability
Item
Result in persistent or significant disability/incapacity
boolean
C0877248 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Adverse Event associated with Hospitalization
Item
Requires in-patient hospitalization.
boolean
C2826664 (UMLS CUI [1])
admission date
Item
Admission date:
date
C1302393 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Discharge date
Item
Discharge date
date
C2361123 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Prolongation of existing hospitalization
Item
Prolongation of existing hospitalization
boolean
C0745041 (UMLS CUI [1])
Discharge date
Item
Discharge date
date
C2361123 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Congenital anomaly
Item
Congenital anomaly / birth defect in the offspring of a study subject.
boolean
C2826727 (UMLS CUI [1])
other event
Item
“Medically important” event specify:
boolean
C1710056 (UMLS CUI [1])
other event
Item
“Medically important” event specify:
text
C1710056 (UMLS CUI [1])
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