ID

35824

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 Concomitant Vaccination form. It has to be filled in for 2 phases: Active phase and after telephone contact phase. At each study visit/telephone contact, the investigator should question the subject' about any vaccine administered.

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

Concomitant Vaccination

Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Phase type
Beschrijving

Phase type

Datatype

integer

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C0332307
Concomitant Vaccination
Beschrijving

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe specified in the protocol?
Beschrijving

Any vaccine not foreseen in the study protocol is to be recorded as a concomitant vaccination with trade name, route of administration and date(s) of administration. Any investigational vaccine administered throughout the study (i.e. from Visit "Day 0" through Visit "Day 42") must be recorded in the eCRF.

Datatype

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Trade / Generic Name of vaccine
Beschrijving

Trade / Generic Name of vaccine

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route of vaccine administration
Beschrijving

Route of vaccine administration

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date of vaccine
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0011008
Comment for GSK
Beschrijving

Comment for GSK

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961

Similar models

Concomitant Vaccination

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
Phase type
integer
C0205390 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Phase type
CL Item
Active Phase (1)
CL Item
after telephone contact (2)
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe specified in the protocol?
text
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe specified in the protocol?
CL Item
No (N)
CL Item
Yes (Y)
Trade / Generic Name of vaccine
Item
Trade / Generic Name of vaccine
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route of vaccine administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Route of vaccine administration
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular  (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Administration date of vaccine
Item
Administration date of vaccine
date
C1533734 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])

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