ID

35777

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 Laboratory test, Influenza serology sample and Urine pregnancy test. The Laboratory test has to be filled in for: Visit 1, Visit 2 and Visit 5. The Influenza serology sample has to be filled in for: Visit 1, Visit 3, Visit 5 and Visit 6. The Urine pregnancy test has to be filled in for: Visit 1 and Visit 3.

Link

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

Keywords

  1. 3/22/19 3/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 22, 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

Laboratory test, Influenza serology sample, Urine pregnancy test

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for Safety Analysis?
Description

This blood sample has to be taken for: Visit 1, Visit 2 and Visit 5.

Data type

text

Alias
UMLS CUI [1]
C0005834
If a blood sample was taken, please note the date if different from visit date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Influenza serology sample
Description

Influenza serology sample

Alias
UMLS CUI-1
C4316910
UMLS CUI-2
C0036743
Has a blood sample been taken for influenza serology (14 mL)?
Description

This sample has to be taken for: Visit 1, Visit 3, Visit 5 and Visit 6. (including vaccine-homologous virus hemaglutination-inhibiting antibody reciprocal titers; drift variant H5N1 virus hemagglutination-inhibiting antibody reciprocal titers; and microneutralization titers against homologous and drift viruses)

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C4316910
UMLS CUI [1,3]
C0036743
If a blood sample was taken, please note the date if different from visit date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C4316910
UMLS CUI [1,3]
C0036743
UMLS CUI [1,4]
C0011008
HCG urine pregnancy test
Description

HCG urine pregnancy test

Alias
UMLS CUI-1
C0430056
Has a urine sample been taken?
Description

The Urine pregnancy test has to be taken for: Visit 1 and Visit 3. NA only for male.

Data type

text

Alias
UMLS CUI [1]
C0200354
Result of urine sample
Description

Result of urine sample

Data type

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0456984
If a urine sample was taken, please note the date if different from visit date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200354

Similar models

Laboratory test, Influenza serology sample, Urine pregnancy test

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
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6  (6)
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken for Safety Analysis?
text
C0005834 (UMLS CUI [1])
Code List
Has a blood sample been taken for Safety Analysis?
CL Item
Yes (Y)
CL Item
No (N)
Date of blood sample
Item
If a blood sample was taken, please note the date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Influenza serology sample
C4316910 (UMLS CUI-1)
C0036743 (UMLS CUI-2)
Item
Has a blood sample been taken for influenza serology (14 mL)?
text
C0005834 (UMLS CUI [1,1])
C4316910 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
Code List
Has a blood sample been taken for influenza serology (14 mL)?
CL Item
Yes (Y)
CL Item
No (N)
Date of blood sample
Item
If a blood sample was taken, please note the date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C4316910 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
HCG urine pregnancy test
C0430056 (UMLS CUI-1)
Item
Has a urine sample been taken?
text
C0200354 (UMLS CUI [1])
Code List
Has a urine sample been taken?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
NA (NA)
Item
Result of urine sample
text
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of urine sample
CL Item
Positive (P)
CL Item
Negative (N)
Date of urine sample
Item
If a urine sample was taken, please note the date if different from visit date
date
C0011008 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])

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