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
Versions (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
- StudyEvent: ODM
Description
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Description
This blood sample has to be taken for: Visit 1, Visit 2 and Visit 5.
Data type
text
Alias
- UMLS CUI [1]
- C0005834
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Influenza serology sample
Alias
- UMLS CUI-1
- C4316910
- UMLS CUI-2
- C0036743
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
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
Description
HCG urine pregnancy test
Alias
- UMLS CUI-1
- C0430056
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
Description
Result of urine sample
Data type
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0456984
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
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0036743 (UMLS CUI-2)
C4316910 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C4316910 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
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