ID

35767

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 Demography and Informed consent form. It has to be filled in for screening.

Link

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

Keywords

Versions (3)
  1. 3/20/19 3/20/19 -
  2. 3/20/19 3/20/19 -
  3. 3/21/19 3/21/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 21, 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

Demography, Informed consent

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
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Center number
Description

Center number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Height (cm unit)
Description

Height (cm unit)

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Height (feet unit)
Description

Only for US.

Data type

integer

Measurement units
  • feet
Alias
UMLS CUI [1]
C0005890
feet
Height (inches unit)
Description

Only for US.

Data type

integer

Measurement units
  • inches
Alias
UMLS CUI [1]
C0005890
inches
Weight (kg unit)
Description

Weight (kg unit)

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight (pounds unit)
Description

Only for US.

Data type

integer

Measurement units
  • pounds
Alias
UMLS CUI [1]
C0005910
pounds
Weight (ounces unit)
Description

Only for US.

Data type

integer

Measurement units
  • ounces
Alias
UMLS CUI [1]
C0005910
ounces
Geographic Ancestry
Description

Geographic Ancestry

Alias
UMLS CUI-1
C0034510
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
African American/African Heritage
Description

African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

Asian - Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

Asian - Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

Asian - South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

White - Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - Caucasian/European Heritage
Description

White - Caucasian/European Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0043157
Other Race
Description

Other Race

Data type

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
If other racial group, please specify
Description

Other Race, specification

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C2348235
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
Description

Agreement to use of biological samples(s) for other research

Data type

text

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0178913
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0035168
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Similar models

Demography, Informed consent

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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Child-bearing potential
Code List
Center number
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Female (F)
(Comment:en)
CL Item
Male (M)
(Comment:en)
Height (cm unit)
Item
Height (cm unit)
integer
C0005890 (UMLS CUI [1])
Height (feet unit)
Item
Height (feet unit)
integer
C0005890 (UMLS CUI [1])
Height (inches unit)
Item
Height (inches unit)
integer
C0005890 (UMLS CUI [1])
Weight (kg unit)
Item
Weight (kg unit)
float
C0005910 (UMLS CUI [1])
Weight (pounds unit)
Item
Weight (pounds unit)
integer
C0005910 (UMLS CUI [1])
Weight (ounces unit)
Item
Weight (ounces unit)
integer
C0005910 (UMLS CUI [1])
Item Group
Geographic Ancestry
C0034510 (UMLS CUI-1)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
White - Caucasian/European Heritage
Item
White - Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Other Race
Item
Other Race
boolean
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Race, specification
Item
If other racial group, please specify
text
C0034510 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
text
C3641827 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0035168 (UMLS CUI [1,5])
Agreeness of use of biological samples(s) for other researches
Code List
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
NA (NA)
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