ID

33929

Description

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Keywords

Versions (1)
  1. 1/8/19 1/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 8, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

English

Serious Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Serious Adverse Event (SAE)
Description

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C3897642
Serious Adverse Event (SAE)
Description

Serious Adverse Event Report

Data type

text

Alias
UMLS CUI [1]
C3897642
Subject Demography
Description

Subject Demography

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1704791
Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C1519255
Diagnosis (or signs and symptoms if not known)
Description

Serious Adverse Event, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Date and time started
Description

Serious Adverse Event, Start Date, Start Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Intensity ™ (maximum)
Description

Serious Adverse Event, Symptom intensity

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
In your opinion, did the vaccine possibly contribute to the SAE?
Description

Serious Adverse Event, Relationship, Vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0042210
Outcome
Description

Serious Adverse Event, Adverse Event Outcome

Data type

text

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

Serious Adverse Event, Action taken with study

Data type

text

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0042210
Events after further ™vaccination
Description

Serious Adverse Event, Vaccination, Continuous, Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0549178
UMLS CUI [1,4]
C0441471
Specify criteria for considering this as a Serious Adverse Event
Description

Serious Adverse Event, Criteria

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0243161
Other events (not SAE) to be reported in the same way
Description

Event, Other

Data type

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205394
Other possible contributors
Description

Serious Adverse Event, Etiology aspects

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0015127
Was subject withdrawn due to this specific SAE?
Description

Serious Adverse Event, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Study vaccine information
Description

Study vaccine information

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C0304229
UMLS CUI-3
C1533716
Vaccine (specify mixed or separate)
Description

Vaccines, Experimental

Data type

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0304229
Dose No
Description

Vaccines, Dose, Number

Data type

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1115464
Lot No
Description

Vaccines, Lot Number

Data type

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1115660
Route / Site
Description

Vaccines, Drug Administration Routes, Anatomical Site

Data type

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C1515974
Date
Description

Vaccines, Date in time

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
C1519255
UMLS CUI-2
C2347852
Drug / Vaccine
Description

Serious Adverse Event, Concomitant Agent

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
Dosage
Description

Serious Adverse Event, Concomitant Agent, Medication dose

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Frequency
Description

Serious Adverse Event, Concomitant Agent, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439603
Route
Description

Serious Adverse Event, Concomitant Agent, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0013153
Start date
Description

Serious Adverse Event, Concomitant Agent, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0808070
End date
Description

Serious Adverse Event, Concomitant Agent, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0806020
Relevant intercurrent illness & medical history hat could have contributed to this SAE
Description

Relevant intercurrent illness & medical history hat could have contributed to this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
Condition
Description

Serious Adverse Event, Disease

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Still present?
Description

Serious Adverse Event, Disease, Present

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0150312
Drug(s) used to treat this SAE
Description

Drug(s) used to treat this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0013227
Drug
Description

Serious Adverse Event, Pharmaceutical Preparations

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
Dosage
Description

Serious Adverse Event, Pharmaceutical Preparations, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0178602
Frequency
Description

Serious Adverse Event, Pharmaceutical Preparations, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439603
Route
Description

Serious Adverse Event, Pharmaceutical Preparations, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0013153
Start date
Description

Serious Adverse Event, Pharmaceutical Preparations, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
End date
Description

Serious Adverse Event, Pharmaceutical Preparations, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0806020
Surgical treatment for this SAE
Description

Surgical treatment for this SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0543467
Surgical treatment for this SAE
Description

Serious Adverse Event, Operative Surgical Procedure

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0543467
Description
Description

Description

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0678257
Description
Description

Serious Adverse Event, Description

Data type

text

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

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Please PRINT Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Comments
Description

Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Comments
Description

Serious Adverse Event, Comment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator signature
Description

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Please PRINT Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Events

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Serious Adverse Event (SAE)
C3897642 (UMLS CUI-1)
Item
Serious Adverse Event (SAE)
text
C3897642 (UMLS CUI [1])
Serious Adverse Event Report
Code List
Serious Adverse Event (SAE)
CL Item
Initial report ™ (Initial report ™)
CL Item
Additional info (Additional info)
CL Item
Additional info (Additional info)
CL Item
Additional info (Additional info)
Item Group
Subject Demography
C1519255 (UMLS CUI-1)
C1704791 (UMLS CUI-2)
Person Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Patient 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 (Male)
CL Item
Female (Female)
Item Group
Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event, Diagnosis
Item
Diagnosis (or signs and symptoms if not known)
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Serious Adverse Event, Start Date, Start Time
Item
Date and time started
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Intensity ™ (maximum)
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Serious Adverse Event, Symptom intensity
Code List
Intensity ™ (maximum)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Serious Adverse Event, Relationship, Vaccines
Item
In your opinion, did the vaccine possibly contribute to the SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event 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
text
C2826626 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Action taken with respect to Study Vaccine
CL Item
None (1)
CL Item
Vaccination course stopped (3)
CL Item
Vaccination course postponed ™  (™2)
Item
Events after further ™vaccination
text
C1519255 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,4])
Serious Adverse Event, Adverse Event Outcome
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)
Item
Specify criteria for considering this as a Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Specify criteria for considering this as a Serious Adverse Event
CL Item
Results in death (Autopsy?) (1)
CL Item
Life threatening (2)
CL Item
Results in persistent or significant disability/ incapacity (™3)
CL Item
Requires in-patient hospitalization (Admission/Discharge Date) (™4)
CL Item
Prolongation of existing hospitalization (Discharge date) (5)
CL Item
Congenital anomaly / birth defect in the offspring of a study subject (6)
CL Item
"Medically important" event (™7)
Item
Other events (not SAE) to be reported in the same way
text
C0441471 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Serious Adverse Event, Adverse Event Outcome
Code List
Other events (not SAE) to be reported in the same way
CL Item
Cancer (Cancer)
Item
Other possible contributors
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Serious Adverse Event, Etiology aspects
Code List
Other possible contributors
CL Item
Medical history (record in section 15) (1)
CL Item
Other medication (record in section 14) (™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, specify (™7)
Serious Adverse Event, Withdraw
Item
Was subject withdrawn due to this specific SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Item Group
Study vaccine information
C0042210 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Vaccines, Experimental
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Vaccines, Dose, Number
Item
Dose No
integer
C0042210 (UMLS CUI [1,1])
C1115464 (UMLS CUI [1,2])
Vaccines, Lot Number
Item
Lot No
integer
C0042210 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Vaccines, Drug Administration Routes, Anatomical Site
Item
Route / Site
text
C0042210 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Vaccines, Date in time
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
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Serious Adverse Event, Concomitant Agent
Item
Drug / Vaccine
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Medication dose
Item
Dosage
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Start date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
End date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Relevant intercurrent illness & medical history hat could have contributed to this SAE
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Serious Adverse Event, Disease
Item
Condition
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Present
Item
Still present?
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Item Group
Drug(s) used to treat this SAE
C1519255 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Serious Adverse Event, Pharmaceutical Preparations
Item
Drug
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Serious Adverse Event, Pharmaceutical Preparations, Dosage
Item
Dosage
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Start Date
Item
Start date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, End Date
Item
End date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Surgical treatment for this SAE
C1519255 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
Serious Adverse Event, Operative Surgical Procedure
Item
Surgical treatment for this SAE
text
C1519255 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Description
C1519255 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
Serious Adverse Event, Description
Item
Description
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
Item Group
Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
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