ID

35775

Beschreibung

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 Check for study continuation. It has to be filled in for each Visit.

Link

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

Stichworte

  1. 22.03.19 22.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. März 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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

Check for study continuation

Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beschreibung

Visit type

Datentyp

integer

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

day month year REMINDER: If Screening Visit and Visit «Day 0» were done at the same day, please fill in Visit «Day 0» with the same date of visit.

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Check for study continuation
Beschreibung

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for this visit?
Beschreibung

Continuation status

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If subject did not return to visit, please tick the ONE most appropriate reason.
Beschreibung

If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.

Datentyp

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0566251
If you ticked SAE as primary reason for no continuation, please specify SAE Number
Beschreibung

SAE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If you ticked AE as primary reason for no continuation, please specify AE Number
Beschreibung

AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If you ticked other reason as primary reason for no continuation, please specify
Beschreibung

(e.g.: consent withdrawal, Protocol violation, …)

Datentyp

text

Alias
UMLS CUI [1]
C3840932
Please tick who made the decision
Beschreibung

Decision taken

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006

Ähnliche Modelle

Check for study continuation

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Did the subject return for this visit?
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the subject return for this visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject did not return to visit, please tick the ONE most appropriate reason.
text
C1298908 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If subject did not return to visit, please tick the ONE most appropriate reason.
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Number
Item
If you ticked SAE as primary reason for no continuation, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
If you ticked AE as primary reason for no continuation, please specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason
Item
If you ticked other reason as primary reason for no continuation, please specify
text
C3840932 (UMLS CUI [1])
Item
Please tick who made the decision
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)

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