ID

25902

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 (2)
  1. 8/23/17 8/23/17 -
  2. 9/26/17 9/26/17 -
Uploaded on

September 26, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION NON SERIOUS ADVERSE EVENTS NCT00291876

English

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION NON SERIOUS ADVERSE EVENTS 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
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
NON-SERIOUS ADVERSE EVENTS
Description

NON-SERIOUS ADVERSE EVENTS

Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Description

(Please report all serious adverse events only on the Serious Adverse Event (SAE) form).

Data type

text

Alias
UMLS CUI [1]
C1518404
NON-SERIOUS ADVERSE EVENTS
Description

NON-SERIOUS ADVERSE EVENTS

AE No.
Description

adverse event number

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Description
Description

adverse event description

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
For GSK
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Local (administration site)
Description

adverse event location

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205276
Non-administration site
Description

adverse event location2

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0450429
Date started
Description

adverse event start date

Data type

date

Alias
UMLS CUI [1]
C2697888
during immediate postvaccination period specified in protocol
Description

immediate post-vaccination reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
Date Stopped
Description

adverse event end date

Data type

date

Alias
UMLS CUI [1]
C2697886
Intensity
Description

adverse event intensity

Data type

integer

Alias
UMLS CUI [1]
C1710066
Causality In your opinion, did the vaccine possibly contribute to this AE?
Description

causality

Data type

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C0877248
Adverse Event Outcome
Description

Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION NON SERIOUS ADVERSE EVENTS 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])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
NON-SERIOUS ADVERSE EVENTS
Item
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
text
C1518404 (UMLS CUI [1])
non serious adverse event
Code List
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (No)
CL Item
Yes, please complete the following table. (Yes, please complete the following table.)
Item Group
NON-SERIOUS ADVERSE EVENTS
adverse event number
Item
AE No.
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
adverse event description
Item
Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
comment
Item
For GSK
text
C0947611 (UMLS CUI [1])
adverse event location
Item
Local (administration site)
boolean
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
adverse event location2
Item
Non-administration site
boolean
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
adverse event start date
Item
Date started
date
C2697888 (UMLS CUI [1])
immediate post-vaccination reaction
Item
during immediate postvaccination period specified in protocol
boolean
C2697888 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
adverse event end date
Item
Date Stopped
date
C2697886 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
adverse event intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
causality
Item
Causality In your opinion, did the vaccine possibly contribute to this AE?
boolean
C3641099 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event 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)
CL Item
fatal (6)
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