ID

33873

Beschreibung

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

Stichworte

Versionen (1)
  1. 04.01.19 04.01.19 -
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GlaxoSmithKline

Hochgeladen am

4. Januar 2019

DOI

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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

Englisch

Non-Serious Adverse Events

1 Formulare  
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

Non-Serious Adverse Event, Administration of vaccine, Post

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Adverse Event No.
Beschreibung

Non-Serious Adverse Event, Numbers

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Beschreibung

Non-Serious Adverse Event, Description

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Description
Beschreibung

Non-Serious Adverse Event, Description

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Date Started
Beschreibung

Non-Serious Adverse Event, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Started during immediate post-vaccination period specified in protocol
Beschreibung

Non-Serious Adverse Event, Start, Vaccination; Post

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
Date Stopped
Beschreibung

Non-Serious Adverse Event, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Intensity
Beschreibung

Non-Serious Adverse Event, Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Causality In your opinion, did the vaccine possibly contribute to this AE?
Beschreibung

Non-Serious Adverse Event, Causality, Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1314792
UMLS CUI [1,3]
C0042210
Outcome
Beschreibung

Non-Serious Adverse Event, Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
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Ähnliche Modelle

Non-Serious Adverse Events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event, Administration of vaccine, Post
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1519255 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Item
Adverse Event No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event, Numbers
Code List
Adverse Event No.
CL Item
AE. 1 (AE. 1)
CL Item
AE. 2 (AE. 2)
CL Item
AE. 3 (AE. 3)
CL Item
AE. 4 (AE. 4)
CL Item
AE. 5 (AE. 5)
CL Item
AE. 6 (AE. 6)
Non-Serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-Serious Adverse Event, Description
Code List
Description
CL Item
Local (injection sites) (Local (injection sites))
CL Item
™General (non injection site) (™General (non injection site))
Non-Serious Adverse Event, Start Date
Item
Date Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event, Start, Vaccination; Post
Item
Started during immediate post-vaccination period specified in protocol
boolean
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
Non-Serious Adverse Event, End Date
Item
Date Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event, Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Non-Serious Adverse Event, Causality, Vaccines
Item
Causality In your opinion, did the vaccine possibly contribute to this AE?
boolean
C1518404 (UMLS CUI [1,1])
C1314792 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered (™1)
CL Item
Recovered with sequelae (™2)
CL Item
Ongoing at subject study conclusion (™3)
CL Item
Died (™4)
CL Item
Unknown (™5)
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