ID

35830

Beschrijving

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 Follow-up studies form. It has to be filled in for the end of study.

Link

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

Trefwoorden

  1. 25-03-19 25-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Follow-up studies

  1. StudyEvent: ODM
    1. Follow-up studies
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Follow-up studies
Beschrijving

Follow-up studies

Alias
UMLS CUI-1
C0016441
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
Beschrijving

Follow-up study, subject's contact

Datatype

text

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0681850
If subject does not want to be contacted for follow-up studies, please specify the most appropriate reason
Beschrijving

No contact for follow-up studies, reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0332158
UMLS CUI [1,4]
C0681850
UMLS CUI [1,5]
C0566251
Specification of reason
Beschrijving

Specification of reason

Datatype

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C2348235

Similar models

Follow-up studies

  1. StudyEvent: ODM
    1. Follow-up studies
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
text
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Code List
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject does not want to be contacted for follow-up studies, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Code List
If subject does not want to be contacted for follow-up studies, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Specification of reason
Item
Specification of reason
text
C1549995 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

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