ID

35826

Description

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Non-serious AE form. At each study visit / contact the investigator should question the subject about any occurrence of AE. All AEs occurring within 21 days following administrations of the two dose of vaccine must be recorded on the Adverse Event form in the subject's CRF, irrespective of intensity or whether or not they are considered vaccinationrelated. Throughout the entire study period, AEs related to new onset chronic diseases must be recorded on the Adverse Event form in the subject’s CRF irrespective of severity or whether they are considered vaccination-related. In order to be characterized as a NOCD, an AE should be: -Absent at baseline evaluation and absent from the medical history, -Unresolved, and not anticipated to resolve, at the time of study termination, and -Likely, in the investigator’s opinion, to require chronic medical care or monitoring to manage an active disease process.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Keywords

Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 25, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

English

Non-Serious Adverse Events (AE)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Phase type
Description

Phase type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within 21 days (Day 0 and 20 subsequent days) after each dose of study vaccine?
Description

If you tick yes, please complete the following items.

Data type

text

Alias
UMLS CUI [1]
C1518404
AE Number
Description

AE Number

Data type

integer

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

AE Description

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
AE Site
Description

AE Site

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0450429
Please check box in case of new onset of chronic diseases.
Description

Throughout the entire study period, AEs related to new onset chronic diseases must be recorded on the Adverse Event form in the subject’s CRF irrespective of severity or whether they are considered vaccination-related. In order to be characterized as a NOCD, an AE should be: -Absent at baseline evaluation and absent from the medical history, -Unresolved, and not anticipated to resolve, at the time of study termination, and -Likely, in the investigator’s opinion, to require chronic medical care or monitoring to manage an active disease process.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0746890
Comment for GSK
Description

Comment for GSK

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
Start Date of AE
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2697888
Tick if AE start during immediate post-vaccination period (30 minutes)
Description

AE start immediate post-vaccination period

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205253
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0042196
Stop Date of AE
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
AE Maximum Intensity
Description

Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An AE which is sufficiently severe to interfere with normal everyday activities. Over-thecounter symptomatic therapy may be used. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an AE would, for example, prevent attendance at work or school and would necessitate the administration of prescription (symptomatic or specific) therapy.

Data type

integer

Alias
UMLS CUI [1,1]
C0806909
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0439849
Outcome of AE
Description

Definition: 1: Recovered / resolved. 2: Recovering / resolving: Subject is recovering at the time she/he completes the study or at the time she/he withdraws from study. 3: Not recovered / not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up; in case of death AEs that are not the cause of death. 4: Recovered with sequelae / resolved with sequelae.

Data type

text

Alias
UMLS CUI [1]
C1705586
Medically attended visit
Description

Medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
If medically attended visit, please specify type
Description

Type of medically attended visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C1518404
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Similar models

Non-Serious Adverse Events (AE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Phase type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Phase type
CL Item
active phase (1)
CL Item
after telephone contact (2)
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Has any non-serious adverse events occurred within 21 days (Day 0 and 20 subsequent days) after each dose of study vaccine?
text
C1518404 (UMLS CUI [1])
Non-serious AE after vaccine dose
Code List
Has any non-serious adverse events occurred within 21 days (Day 0 and 20 subsequent days) after each dose of study vaccine?
CL Item
No (N)
CL Item
Yes (Y)
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Description
Item
AE Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
AE Site
text
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
AE Site
Code List
AE Site
CL Item
Administration site (L)
CL Item
Non-administration site (G)
New onset of chronic diseases
Item
Please check box in case of new onset of chronic diseases.
boolean
C0008679 (UMLS CUI [1,1])
C0746890 (UMLS CUI [1,2])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Start Date of AE
Item
Start Date of AE
date
C2697888 (UMLS CUI [1])
AE start immediate post-vaccination period
Item
Tick if AE start during immediate post-vaccination period (30 minutes)
boolean
C0877248 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Stop Date of AE
Item
Stop Date of AE
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
AE Maximum Intensity
integer
C0806909 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
AE Maximum Intensity
Code List
AE Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
AE Relationship to investigational products
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Item
Outcome of AE
text
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of AE
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item
If medically attended visit, please specify type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Medically attended visit
Code List
If medically attended visit, please specify type
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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