ID

26121

Description

Study ID: 111029 Clinical Study ID: 111029 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 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 Documentation part: Serious Adverse Event

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Serious Adverse Event 111029

English

Serious Adverse Event Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029

1 forms  
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0170300
Serious Adverse Event
Description

Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1519255
Initials
Description

Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Serious adverse events: Diagnosis only (if known) or signs / symptoms
Description

Diagnosis Serious adverse events

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Specify criteria for considering this as a Serious Adverse Event.
Description

Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1519255
Autopsy
Description

If "Result in death"=Yes, please specify Send autopsy report when available

Data type

boolean

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C1519255
Admission date
Description

If "Requires in-patient hospitalization"=Yes, please specify

Data type

date

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

If "Requires in-patient hospitalization"=Yes, please specify

Data type

date

Alias
UMLS CUI [1]
C2361123
UMLS CUI [2]
C1519255
Discharge date
Description

If "Prolongation of existing hospitalization"=Yes, please specify

Data type

date

Alias
UMLS CUI [1]
C2361123
UMLS CUI [2]
C1519255
Medically important event
Description

If "Medically important event"=Yes, please specify

Data type

text

Alias
UMLS CUI [1]
C2826307
Other events (not SAE) to be reported in the same way
Description

=Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C2826307
Start Date
Description

Start Date

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Time started
Description

Time started

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1519255
End Date
Description

(If ongoing please leave blank)

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Time stopped
Description

(If ongoing please leave blank)

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1519255
Maximum Intensity
Description

Maximum Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1519255
In your opinion, did the vaccine possibly contribute to the SAE :
Description

Relationship to vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0170300
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1519255
Other possible contributors:
Description

Cause of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Please specify cause of SAE if Other
Description

Cause of SAE

Data type

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Outcome
Description

Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Action taken with respect to study vaccine
Description

Action taken with respect to study vaccine

Data type

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0170300
UMLS CUI [1,3]
C1519255
Events after further vaccination
Description

Events after further vaccination

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1519255
Was subject withdrawn due to this specific SAE ?
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Relevant intercurrent illness & medical history that could have contributed to this SAE
Description

Relevant Medical Conditions

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1519255
Condition still present?
Description

Condition still present

Data type

boolean

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C1519255
Description
Description

(provide a brief narrative description of the SAE including relevant diagnostic findings, lab data & evolution of the events etc…)

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Study vaccine information
Description

Study vaccine information

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0170300
UMLS CUI-3
C0304229
Vaccine
Description

Vaccine

Data type

text

Alias
UMLS CUI [1]
C0042210
Dose No
Description

Dose No

Data type

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0449788
UMLS CUI [2]
C0042210
Lot No
Description

Lot Number

Data type

integer

Alias
UMLS CUI [1]
C2826710
UMLS CUI [2]
C0042210
Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Site
Description

Site

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0011008
Concomitant medication / vaccination that could have contributed to this SAE
Description

Concomitant medication / vaccination that could have contributed to this SAE

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0042210
Relevant Concomitant Medications: Drug/vaccine name
Description

Concomitant medication / vaccination that could have contributed to this SAE

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Dosage
Description

Dosage

Data type

float

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Relevant Concomitant Medications: Stop date
Description

Stop date

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
UMLS CUI [2]
C1519255
Drug(s) used to treat this SAE
Description

Drug(s) used to treat this SAE

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
UMLS CUI-3
C1519255
Drug name
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C2360065
Dosage
Description

Dosage

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0013227
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

End date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Surgical treatment for this SAE, please specify
Description

Surgical treatment

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
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Similar models

Serious Adverse Event Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
Item
Serious Adverse Event
integer
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Serious Adverse Event
CL Item
Initial report (1)
CL Item
Additional info (2)
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Diagnosis Serious adverse events
Item
Serious adverse events: Diagnosis only (if known) or signs / symptoms
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Specify criteria for considering this as a Serious Adverse Event.
integer
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Specify criteria for considering this as a Serious Adverse Event.
CL Item
Result in death (1)
CL Item
Life threatening (2)
CL Item
Result in persistent or significant disability/incapacity (3)
CL Item
Requires in-patient hospitalization. (4)
CL Item
Prolongation of existing hospitalization (5)
CL Item
Congenital anomaly / birth defect in the offspring of a study subject. (6)
CL Item
“Medically important” event (7)
autopsy
Item
Autopsy
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Admission date
Item
Admission date
date
C1302393 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Discharge date
Item
Discharge date
date
C2361123 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
discharge date
Item
Discharge date
date
C2361123 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Medically important event
Item
Medically important event
text
C2826307 (UMLS CUI [1])
Other events
Item
Other events (not SAE) to be reported in the same way
boolean
C0006826 (UMLS CUI [1])
C2826307 (UMLS CUI [2])
Start Date
Item
Start Date
text
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Time started
Item
Time started
time
C0040223 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Time stopped
Item
Time stopped
time
C0040223 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Relationship to vaccine
Item
In your opinion, did the vaccine possibly contribute to the SAE :
boolean
C0304229 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item
Other possible contributors:
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Cause of SAE
Code List
Other possible contributors:
CL Item
Medical history  (1)
CL Item
Other medication (2)
CL Item
Protocol required procedure (3)
CL Item
Other procedure (4)
CL Item
Lack of efficacy (5)
CL Item
Erroneous administration (6)
CL Item
Other (7)
Cause of SAE
Item
Please specify cause of SAE if Other
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
Item
Action taken with respect to study vaccine
integer
C1704758 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Action taken with respect to study vaccine
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
C0042196 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Events after further vaccination
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)
Withdrawal
Item
Was subject withdrawn due to this specific SAE ?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relevant Medical Conditions
Item
Relevant intercurrent illness & medical history that could have contributed to this SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Condition still present
Item
Condition still present?
boolean
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Item Group
Study vaccine information
C0042210 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Dose No
Item
Dose No
integer
C3174092 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
Lot Number
Item
Lot No
integer
C2826710 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Site
Item
Site
text
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Date
Item
Date
date
C0042210 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Concomitant medication / vaccination that could have contributed to this SAE
C2347852 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Drug or vaccine name
Item
Relevant Concomitant Medications: Drug/vaccine name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Dosage
Item
Relevant Concomitant Medications: Dosage
float
C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Frequency
Item
Relevant Concomitant Medications: Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Route
Item
Relevant Concomitant Medications: Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Start Date
Item
Relevant Concomitant Medications: Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Stop date
Item
Relevant Concomitant Medications: Stop date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Item Group
Drug(s) used to treat this SAE
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Surgical treatment
Item
Surgical treatment for this SAE, please specify
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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