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)
- 3/20/19 3/20/19 -
- 3/20/19 3/20/19 -
- 3/21/19 3/21/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
March 21, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Demography, Informed consent
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Center number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Height (cm unit)
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Only for US.
Data type
integer
Measurement units
- feet
Alias
- UMLS CUI [1]
- C0005890
Description
Only for US.
Data type
integer
Measurement units
- inches
Alias
- UMLS CUI [1]
- C0005890
Description
Weight (kg unit)
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Only for US.
Data type
integer
Measurement units
- pounds
Alias
- UMLS CUI [1]
- C0005910
Description
Only for US.
Data type
integer
Measurement units
- ounces
Alias
- UMLS CUI [1]
- C0005910
Description
Geographic Ancestry
Alias
- UMLS CUI-1
- C0034510
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
African American/African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
American Indian or Alaskan Native
Data type
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
Asian - Central/South Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
Asian - East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
Asian - Japanese Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
Asian - South East Asian Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
Native Hawaiian or Other Pacific Islander
Data type
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
White - Arabic/North African Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Description
White - Caucasian/European Heritage
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Description
Other Race
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Description
Other Race, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Description
Informed consent
Alias
- UMLS CUI-1
- C0021430
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
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
Similar models
Demography, Informed consent
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0035168 (UMLS CUI [1,5])